{
"NDC": [
{
"NDCCode": "50222-280-99",
"PackageDescription": "1 TUBE in 1 CARTON (50222-280-99) / 5 g in 1 TUBE",
"NDC11Code": "50222-0280-99",
"ProductNDC": "50222-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzupgo",
"NonProprietaryName": "Delgocitinib",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219155",
"LabelerName": "LEO Pharma, Inc",
"SubstanceName": "DELGOCITINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250830",
"SamplePackage": "Y",
"IndicationAndUsage": "ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.",
"Description": "ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water."
},
{
"NDCCode": "50222-260-99",
"PackageDescription": "25 CARTON in 1 CASE (50222-260-99) > 10 TUBE in 1 CARTON > 3 g in 1 TUBE",
"NDC11Code": "50222-0260-99",
"ProductNDC": "50222-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dovonex",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020554",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
},
{
"NDCCode": "50222-280-30",
"PackageDescription": "1 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE",
"NDC11Code": "50222-0280-30",
"ProductNDC": "50222-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzupgo",
"NonProprietaryName": "Delgocitinib",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219155",
"LabelerName": "LEO Pharma, Inc",
"SubstanceName": "DELGOCITINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250724",
"SamplePackage": "N",
"IndicationAndUsage": "ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.",
"Description": "ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water."
},
{
"NDCCode": "50222-280-91",
"PackageDescription": "1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE",
"NDC11Code": "50222-0280-91",
"ProductNDC": "50222-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzupgo",
"NonProprietaryName": "Delgocitinib",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219155",
"LabelerName": "LEO Pharma, Inc",
"SubstanceName": "DELGOCITINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250724",
"SamplePackage": "Y",
"IndicationAndUsage": "ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.",
"Description": "ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water."
},
{
"NDCCode": "59651-280-99",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-280-99) ",
"NDC11Code": "59651-0280-99",
"ProductNDC": "59651-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090778",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .",
"Description": "Duloxetine delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "80777-280-99",
"PackageDescription": "10 VIAL in 1 CARTON (80777-280-99) > 2.5 mL in 1 VIAL (80777-280-05) ",
"NDC11Code": "80777-0280-99",
"ProductNDC": "80777-280",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Moderna Covid-19 Vaccine, Bivalent",
"NonProprietaryName": "Moderna Covid-19 Vaccine, Bivalent",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20220613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Moderna US, Inc.",
"SubstanceName": "IMELASOMERAN",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220613",
"SamplePackage": "N"
},
{
"NDCCode": "70573-605-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70573-605-01) / 50 mL in 1 VIAL, GLASS (70573-605-02) ",
"NDC11Code": "70573-0605-01",
"ProductNDC": "70573-605",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Yimmugo",
"NonProprietaryName": "Immune Globulin Intravenous, Human - Dira",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125810",
"LabelerName": "Kedrion Biopharma Inc",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.",
"Description": "YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "70573-605-11",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70573-605-11) / 100 mL in 1 VIAL, GLASS (70573-605-12) ",
"NDC11Code": "70573-0605-11",
"ProductNDC": "70573-605",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Yimmugo",
"NonProprietaryName": "Immune Globulin Intravenous, Human - Dira",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125810",
"LabelerName": "Kedrion Biopharma Inc",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.",
"Description": "YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "70573-605-21",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70573-605-21) / 200 mL in 1 VIAL, GLASS (70573-605-22) ",
"NDC11Code": "70573-0605-21",
"ProductNDC": "70573-605",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Yimmugo",
"NonProprietaryName": "Immune Globulin Intravenous, Human - Dira",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125810",
"LabelerName": "Kedrion Biopharma Inc",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.",
"Description": "YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "79570-001-02",
"PackageDescription": "280 mL in 1 BAG (79570-001-02) ",
"NDC11Code": "79570-0001-02",
"ProductNDC": "79570-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salusen Premium 75% Disinfectant Wipes",
"NonProprietaryName": "Disinfectant Wipes",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200724",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Anhui Wenerjia Medical Devices Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N",
"IndicationAndUsage": "Premium 75% Alcohol Disinfectant Wipes is effective for disinfection and sanitation, able to kill 99.99% of viruses and bacteria in just 10 seconds."
},
{
"NDCCode": "83372-605-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (83372-605-01) / 50 mL in 1 VIAL, GLASS (83372-605-02) ",
"NDC11Code": "83372-0605-01",
"ProductNDC": "83372-605",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Yimmugo",
"NonProprietaryName": "Immune Globulin Intravenous, Human - Dira",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125810",
"LabelerName": "Biotest AG",
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"IndicationAndUsage": "YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.",
"Description": "YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
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"PackageDescription": "1 VIAL, GLASS in 1 CARTON (83372-605-11) / 100 mL in 1 VIAL, GLASS (83372-605-12) ",
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"ProductNDC": "83372-605",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Yimmugo",
"NonProprietaryName": "Immune Globulin Intravenous, Human - Dira",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125810",
"LabelerName": "Biotest AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-05",
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"IndicationAndUsage": "YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.",
"Description": "YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
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"PackageDescription": "1 VIAL, GLASS in 1 CARTON (83372-605-21) / 200 mL in 1 VIAL, GLASS (83372-605-22) ",
"NDC11Code": "83372-0605-21",
"ProductNDC": "83372-605",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Yimmugo",
"NonProprietaryName": "Immune Globulin Intravenous, Human - Dira",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125810",
"LabelerName": "Biotest AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.",
"Description": "YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "50222-203-10",
"PackageDescription": "1 TUBE in 1 CARTON (50222-203-10) > 100 g in 1 TUBE",
"NDC11Code": "50222-0203-10",
"ProductNDC": "50222-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-203-30",
"PackageDescription": "1 TUBE in 1 CARTON (50222-203-30) > 30 g in 1 TUBE",
"NDC11Code": "50222-0203-30",
"ProductNDC": "50222-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-203-60",
"PackageDescription": "1 TUBE in 1 CARTON (50222-203-60) > 60 g in 1 TUBE",
"NDC11Code": "50222-0203-60",
"ProductNDC": "50222-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-211-10",
"PackageDescription": "1 TUBE in 1 CARTON (50222-211-10) > 100 g in 1 TUBE",
"NDC11Code": "50222-0211-10",
"ProductNDC": "50222-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-211-30",
"PackageDescription": "1 TUBE in 1 CARTON (50222-211-30) > 30 g in 1 TUBE",
"NDC11Code": "50222-0211-30",
"ProductNDC": "50222-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-211-60",
"PackageDescription": "1 TUBE in 1 CARTON (50222-211-60) > 60 g in 1 TUBE",
"NDC11Code": "50222-0211-60",
"ProductNDC": "50222-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protopic",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20001208",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160819",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "50222-227-04",
"PackageDescription": "1 TUBE in 1 CARTON (50222-227-04) / 60 g in 1 TUBE",
"NDC11Code": "50222-0227-04",
"ProductNDC": "50222-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taclonex",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021852",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080601",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Taclonex® Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "Taclonex® (calcipotriene and betamethasone dipropionate) Ointment, 0.005%/0.064% contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analogue. Chemically, calcipotriene hydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol,hydrate, with the empirical formula C27H40O3,H2O, a molecular weight of 430.6, and the following structural formula. Calcipotriene hydrate is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta), 17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Taclonex® Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, and white petrolatum."
},
{
"NDCCode": "50222-227-07",
"PackageDescription": "25 CARTON in 1 CASE (50222-227-07) > 10 TUBE in 1 CARTON > 3 g in 1 TUBE",
"NDC11Code": "50222-0227-07",
"ProductNDC": "50222-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taclonex",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021852",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-01-29"
},
{
"NDCCode": "50222-227-81",
"PackageDescription": "1 TUBE in 1 CARTON (50222-227-81) > 100 g in 1 TUBE",
"NDC11Code": "50222-0227-81",
"ProductNDC": "50222-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taclonex",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021852",
"LabelerName": "LEO Pharma Inc",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20080601",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N"
},
{
"NDCCode": "50222-260-06",
"PackageDescription": "1 TUBE in 1 CARTON (50222-260-06) > 60 g in 1 TUBE",
"NDC11Code": "50222-0260-06",
"ProductNDC": "50222-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dovonex",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961001",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020554",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961001",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
},
{
"NDCCode": "50222-260-12",
"PackageDescription": "1 TUBE in 1 CARTON (50222-260-12) > 120 g in 1 TUBE",
"NDC11Code": "50222-0260-12",
"ProductNDC": "50222-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dovonex",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961001",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020554",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961001",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N"
},
{
"NDCCode": "50222-302-60",
"PackageDescription": "1 CAN in 1 CARTON (50222-302-60) > 60 g in 1 CAN",
"NDC11Code": "50222-0302-60",
"ProductNDC": "50222-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enstilar",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207589",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151016",
"SamplePackage": "N",
"IndicationAndUsage": "Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.",
"Description": "Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only."
},
{
"NDCCode": "50222-302-66",
"PackageDescription": "2 CAN in 1 CARTON (50222-302-66) > 60 g in 1 CAN",
"NDC11Code": "50222-0302-66",
"ProductNDC": "50222-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enstilar",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207589",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151016",
"SamplePackage": "N",
"IndicationAndUsage": "Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.",
"Description": "Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only."
},
{
"NDCCode": "50222-302-91",
"PackageDescription": "1 CAN in 1 CARTON (50222-302-91) > 60 g in 1 CAN",
"NDC11Code": "50222-0302-91",
"ProductNDC": "50222-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enstilar",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207589",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151016",
"SamplePackage": "Y",
"IndicationAndUsage": "Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.",
"Description": "Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only."
},
{
"NDCCode": "50222-303-50",
"PackageDescription": "1 CAN in 1 CARTON (50222-303-50) > 50 g in 1 CAN",
"NDC11Code": "50222-0303-50",
"ProductNDC": "50222-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finacea Foam",
"NonProprietaryName": "Azelaic Acid",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207071",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "AZELAIC ACID",
"StrengthNumber": ".15",
"StrengthUnit": "g/g",
"Pharm_Classes": "Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]",
"Status": "Active",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.",
"Description": "FINACEA (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is. Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22. The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of FINACEA Foam, 15% contains 0.15 g of azelaic acid. FINACEA Foam also contains benzoic acid (as a preservative), cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide (to adjust pH), and xanthan gum as inactive ingredients."
},
{
"NDCCode": "50222-303-91",
"PackageDescription": "1 CAN in 1 CARTON (50222-303-91) > 15 g in 1 CAN",
"NDC11Code": "50222-0303-91",
"ProductNDC": "50222-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finacea Foam",
"NonProprietaryName": "Azelaic Acid",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207071",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "AZELAIC ACID",
"StrengthNumber": ".15",
"StrengthUnit": "g/g",
"Pharm_Classes": "Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]",
"Status": "Active",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "Y",
"IndicationAndUsage": "FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.",
"Description": "FINACEA (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is. Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22. The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of FINACEA Foam, 15% contains 0.15 g of azelaic acid. FINACEA Foam also contains benzoic acid (as a preservative), cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide (to adjust pH), and xanthan gum as inactive ingredients."
},
{
"NDCCode": "50222-342-08",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (50222-342-08) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "50222-0342-08",
"ProductNDC": "50222-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Innohep",
"NonProprietaryName": "Tinzaparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020484",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "TINZAPARIN SODIUM",
"StrengthNumber": "20000",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-08-02"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50222-280-99</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-280-99) / 5 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0280-99</NDC11Code>
<ProductNDC>50222-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzupgo</ProprietaryName>
<NonProprietaryName>Delgocitinib</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219155</ApplicationNumber>
<LabelerName>LEO Pharma, Inc</LabelerName>
<SubstanceName>DELGOCITINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250830</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.</IndicationAndUsage>
<Description>ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>50222-260-99</NDCCode>
<PackageDescription>25 CARTON in 1 CASE (50222-260-99) > 10 TUBE in 1 CARTON > 3 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0260-99</NDC11Code>
<ProductNDC>50222-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dovonex</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020554</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>50222-280-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0280-30</NDC11Code>
<ProductNDC>50222-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzupgo</ProprietaryName>
<NonProprietaryName>Delgocitinib</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219155</ApplicationNumber>
<LabelerName>LEO Pharma, Inc</LabelerName>
<SubstanceName>DELGOCITINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.</IndicationAndUsage>
<Description>ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>50222-280-91</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0280-91</NDC11Code>
<ProductNDC>50222-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzupgo</ProprietaryName>
<NonProprietaryName>Delgocitinib</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219155</ApplicationNumber>
<LabelerName>LEO Pharma, Inc</LabelerName>
<SubstanceName>DELGOCITINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.</IndicationAndUsage>
<Description>ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>59651-280-99</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-280-99) </PackageDescription>
<NDC11Code>59651-0280-99</NDC11Code>
<ProductNDC>59651-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090778</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>80777-280-99</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (80777-280-99) > 2.5 mL in 1 VIAL (80777-280-05) </PackageDescription>
<NDC11Code>80777-0280-99</NDC11Code>
<ProductNDC>80777-280</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Moderna Covid-19 Vaccine, Bivalent</ProprietaryName>
<NonProprietaryName>Moderna Covid-19 Vaccine, Bivalent</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20220613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>IMELASOMERAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70573-605-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70573-605-01) / 50 mL in 1 VIAL, GLASS (70573-605-02) </PackageDescription>
<NDC11Code>70573-0605-01</NDC11Code>
<ProductNDC>70573-605</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Yimmugo</ProprietaryName>
<NonProprietaryName>Immune Globulin Intravenous, Human - Dira</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125810</ApplicationNumber>
<LabelerName>Kedrion Biopharma Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.</IndicationAndUsage>
<Description>YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>70573-605-11</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70573-605-11) / 100 mL in 1 VIAL, GLASS (70573-605-12) </PackageDescription>
<NDC11Code>70573-0605-11</NDC11Code>
<ProductNDC>70573-605</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Yimmugo</ProprietaryName>
<NonProprietaryName>Immune Globulin Intravenous, Human - Dira</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125810</ApplicationNumber>
<LabelerName>Kedrion Biopharma Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.</IndicationAndUsage>
<Description>YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>70573-605-21</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70573-605-21) / 200 mL in 1 VIAL, GLASS (70573-605-22) </PackageDescription>
<NDC11Code>70573-0605-21</NDC11Code>
<ProductNDC>70573-605</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Yimmugo</ProprietaryName>
<NonProprietaryName>Immune Globulin Intravenous, Human - Dira</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125810</ApplicationNumber>
<LabelerName>Kedrion Biopharma Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.</IndicationAndUsage>
<Description>YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>79570-001-02</NDCCode>
<PackageDescription>280 mL in 1 BAG (79570-001-02) </PackageDescription>
<NDC11Code>79570-0001-02</NDC11Code>
<ProductNDC>79570-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salusen Premium 75% Disinfectant Wipes</ProprietaryName>
<NonProprietaryName>Disinfectant Wipes</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200724</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Anhui Wenerjia Medical Devices Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Premium 75% Alcohol Disinfectant Wipes is effective for disinfection and sanitation, able to kill 99.99% of viruses and bacteria in just 10 seconds.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83372-605-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (83372-605-01) / 50 mL in 1 VIAL, GLASS (83372-605-02) </PackageDescription>
<NDC11Code>83372-0605-01</NDC11Code>
<ProductNDC>83372-605</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Yimmugo</ProprietaryName>
<NonProprietaryName>Immune Globulin Intravenous, Human - Dira</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125810</ApplicationNumber>
<LabelerName>Biotest AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
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<IndicationAndUsage>YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.</IndicationAndUsage>
<Description>YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
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<Description>YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
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<IndicationAndUsage>YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.</IndicationAndUsage>
<Description>YIMMUGO, immune globulin intravenous, human – dira, is a highly purified, sterile, non-pyrogenic, ready-to-use 10% liquid preparation of concentrated polyclonal human immune globulin G (IgG) antibodies for intravenous administration. The product is a clear to slightly opalescent liquid, which is colorless to pale yellow. The active ingredient is human IgG purified from human Source Plasma and processed using a combination of cold ethanol fractionation, caprylic acid precipitation, as well as anion and cation exchange chromatography. YIMMUGO contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG. The distribution of IgG subclasses is similar to that of normal plasma. YIMMUGO is formulated in water for injection containing 0.27 to 0.33 mmol/mL glycine, 2 to 20 mcg/mL polysorbate 80, with pH 4.4 to 5.2 and osmolality ranges of 280 to 380 mOsmol/kg. YIMMUGO contains not more than 300 mcg/mL of IgA. YIMMUGO does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives. YIMMUGO is prepared from pooled plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of YIMMUGO is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 10 4 IU/mL in the manufacturing pool. The manufacturing process of YIMMUGO employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include caprylic acid, low pH treatment, anion exchange chromatography (AEX) and nanofiltration. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. n.d. not determined. * Polymerase chain reaction (PCR) was used to quantify B19V and HEV genome counts (all other viruses were quantified by in-vitro infectivity assays, using mammalian cell lines). † Log 10 reduction factors of 1 or smaller were not considered for calculation of total virus clearance. BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; PRV, pseudorabies virus, a model for hepatitis B virus;. EMCV, encephalomyocarditis virus, a model for hepatitis A virus; B19V, parvovirus B19; PPV, porcine parvovirus, a model for B19V; HEV, hepatitis E virus. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD. Several of the production steps have been shown to decrease TSE infectivity of the experimental model agent. TSE reduction steps include caprylic acid treatment followed by depth filtration (in sequence, a total of ≥ 5.99 log 10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
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<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
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<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
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<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
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<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>50222-211-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-211-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0211-60</NDC11Code>
<ProductNDC>50222-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protopic</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20001208</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>LEO Pharma Inc</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160819</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Protopic® Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Protopic® (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of Protopic® Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>50222-227-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-227-04) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0227-04</NDC11Code>
<ProductNDC>50222-227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taclonex</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021852</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Taclonex® Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>Taclonex® (calcipotriene and betamethasone dipropionate) Ointment, 0.005%/0.064% contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analogue. Chemically, calcipotriene hydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol,hydrate, with the empirical formula C27H40O3,H2O, a molecular weight of 430.6, and the following structural formula. Calcipotriene hydrate is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta), 17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Taclonex® Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50222-227-07</NDCCode>
<PackageDescription>25 CARTON in 1 CASE (50222-227-07) > 10 TUBE in 1 CARTON > 3 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0227-07</NDC11Code>
<ProductNDC>50222-227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taclonex</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021852</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>50222-227-81</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-227-81) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0227-81</NDC11Code>
<ProductNDC>50222-227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taclonex</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021852</ApplicationNumber>
<LabelerName>LEO Pharma Inc</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080601</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50222-260-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-260-06) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0260-06</NDC11Code>
<ProductNDC>50222-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dovonex</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020554</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961001</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50222-260-12</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-260-12) > 120 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0260-12</NDC11Code>
<ProductNDC>50222-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dovonex</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020554</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961001</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50222-302-60</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (50222-302-60) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0302-60</NDC11Code>
<ProductNDC>50222-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enstilar</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207589</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.</IndicationAndUsage>
<Description>Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>50222-302-66</NDCCode>
<PackageDescription>2 CAN in 1 CARTON (50222-302-66) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0302-66</NDC11Code>
<ProductNDC>50222-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enstilar</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207589</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.</IndicationAndUsage>
<Description>Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>50222-302-91</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (50222-302-91) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0302-91</NDC11Code>
<ProductNDC>50222-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enstilar</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207589</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151016</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.</IndicationAndUsage>
<Description>Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>50222-303-50</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (50222-303-50) > 50 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0303-50</NDC11Code>
<ProductNDC>50222-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finacea Foam</ProprietaryName>
<NonProprietaryName>Azelaic Acid</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207071</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>AZELAIC ACID</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.</IndicationAndUsage>
<Description>FINACEA (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is. Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22. The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of FINACEA Foam, 15% contains 0.15 g of azelaic acid. FINACEA Foam also contains benzoic acid (as a preservative), cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide (to adjust pH), and xanthan gum as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>50222-303-91</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (50222-303-91) > 15 g in 1 CAN</PackageDescription>
<NDC11Code>50222-0303-91</NDC11Code>
<ProductNDC>50222-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finacea Foam</ProprietaryName>
<NonProprietaryName>Azelaic Acid</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207071</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>AZELAIC ACID</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.</IndicationAndUsage>
<Description>FINACEA (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is. Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22. The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of FINACEA Foam, 15% contains 0.15 g of azelaic acid. FINACEA Foam also contains benzoic acid (as a preservative), cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide (to adjust pH), and xanthan gum as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>50222-342-08</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (50222-342-08) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>50222-0342-08</NDC11Code>
<ProductNDC>50222-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Innohep</ProprietaryName>
<NonProprietaryName>Tinzaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020484</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>TINZAPARIN SODIUM</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-02</LastUpdate>
</NDC>
</NDCList>