{
"NDC": [
{
"NDCCode": "64764-944-07",
"PackageDescription": "5 CARTON in 1 TRAY (64764-944-07) > 1 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "64764-0944-07",
"ProductNDC": "64764-944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Edarbyclor",
"NonProprietaryName": "Azilsartan Medoxomil And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111223",
"EndMarketingDate": "20180501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202331",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE",
"StrengthNumber": "40; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-05-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "67046-944-07",
"PackageDescription": "7 TABLET in 1 BLISTER PACK (67046-944-07)",
"NDC11Code": "67046-0944-07",
"ProductNDC": "67046-944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071322",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Diazepam Tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam Tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Diazepam Tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C 16H 13ClN 2O M.W. 284.75. Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate."
},
{
"NDCCode": "64764-944-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (64764-944-30)",
"NDC11Code": "64764-0944-30",
"ProductNDC": "64764-944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Edarbyclor",
"NonProprietaryName": "Azilsartan Medoxomil And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111223",
"EndMarketingDate": "20180501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202331",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE",
"StrengthNumber": "40; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-05-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "64764-944-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (64764-944-90)",
"NDC11Code": "64764-0944-90",
"ProductNDC": "64764-944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Edarbyclor",
"NonProprietaryName": "Azilsartan Medoxomil And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111223",
"EndMarketingDate": "20180501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202331",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE",
"StrengthNumber": "40; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-05-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0944-2656-03",
"PackageDescription": "1 KIT in 1 CARTON (0944-2656-03) * 96 mL in 1 BOTTLE (0338-0001-77) * 96 mL in 1 BOTTLE (64764-512-96) * 100 mL in 1 BOTTLE (0944-2657-07) ",
"NDC11Code": "00944-2656-03",
"ProductNDC": "0944-2656",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard",
"ProprietaryNameSuffix": "S/d",
"NonProprietaryName": "Immune Globulin Intravenous (human)",
"DosageFormName": "KIT",
"StartMarketingDate": "19940510",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103133",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19940510",
"SamplePackage": "N",
"IndicationAndUsage": "GAMMAGARD S/D is an Immune Globulin Intravenous (Human) indicated for: 1 Treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age or older. (1), 2 Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL). (1), 3 Prevention and/or control of bleeding in adult chronic idiopathic thrombocytopenic purpura (ITP) patients. (1), 4 Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. (1).",
"Description": "GAMMAGARD S/D, Immune Globulin Intravenous (Human), IgA less than 1 µg/mL in a 5% Solution (IgA < 1 µg/mL), is GAMMAGARD S/D selected to have an IgA concentration of less than 1 µg/mL of IgA in a 5% solution. GAMMAGARD S/D is a solvent/detergent treated, sterile, freeze-dried preparation of purified immunoglobulin G (IgG) derived from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography steps. The distribution of IgG subclasses present in this product is similar to that in normal plasma. The Fc portion is maintained intact. When reconstituted with the total volume of diluent (Sterile Water for Injection, USP) supplied and reconstituted to 5% solution, the product contains approximately 50 mg/mL of protein, of which at least 90% is gamma globulin. GAMMAGARD S/D contains < 1 µg/mL of IgA in a 5% solution and IgM is present in trace amounts. GAMMAGARD S/D contains all of the IgG antibody activities which are present in the donor population. The product, after reconstituted to 5% solution, contains a physiological concentration of sodium chloride (approximately 8.5 mg/mL) and has a pH of 6.8 ± 0.4. Stabilizing agents and additional components are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin (Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG), 1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100 µg/mL polysorbate 80. GAMMAGARD S/D contains no preservative. To prepare a 10% (100 mg/mL) solution for infusion, add half the volume of diluent, as described in Dosage and Administration (2.1). The content of the stabilizing agents and other components, including IgA, for the 10% solution will be doubled compared to the 5% solution. Screening against potentially infectious agents in the product begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of GAMMAGARD S/D is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (HIV-1/HIV-2) and hepatitis C virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed nucleic acid testing (NAT) and found negative. The manufacturing process includes treatment with an organic solvent/detergent mixture12,13, composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80. The GAMMAGARD S/D manufacturing process provides for viral reduction in in vitro studies. These studies, summarized in Table 6 demonstrate virus clearance during GAMMAGARD S/D manufacturing using human immunodeficiency virus, Type 1 (HIV-1), as the relevant virus and model for HIV-2; bovine viral diarrhea virus (BVDV), a model virus for enveloped RNA viruses such as hepatitis C virus (HCV); pseudorabies virus (PRV), a generic model virus for enveloped DNA viruses such as hepatitis B virus (HBV); encephalomyocarditis virus (EMCV), a model for non-enveloped RNA viruses such as hepatitis A virus (HAV); HAV; and mice minute virus (MMV), a model for small non-enveloped DNA viruses such as human parvovirus B19 (B19V). These reductions are achieved through partitioning and inactivation during cold ethanol fractionation, and the solvent/detergent treatment."
},
{
"NDCCode": "64764-119-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-07) ",
"NDC11Code": "64764-0119-07",
"ProductNDC": "64764-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colcrys",
"NonProprietaryName": "Colchicine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022352",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090901",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "COLCRYS (colchicine, USP) is an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1)., 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).",
"Description": "Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine occurs as a pale yellow powder that is soluble in water. COLCRYS (colchicine, USP) tablets are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575\" × 0.3030\"), debossed with \"AR 374\" on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin."
},
{
"NDCCode": "64764-310-07",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64764-310-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64764-0310-07",
"ProductNDC": "64764-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actoplus Met",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Pioglitazone And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100611",
"EndMarketingDate": "20220930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022024",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "1000; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100611",
"EndMarketingDatePackage": "20220930",
"SamplePackage": "N"
},
{
"NDCCode": "64764-510-07",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64764-510-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64764-0510-07",
"ProductNDC": "64764-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actoplus Met",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Pioglitazone And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100611",
"EndMarketingDate": "20220930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022024",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "1000; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100611",
"EndMarketingDatePackage": "20220930",
"SamplePackage": "N"
},
{
"NDCCode": "64764-550-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (64764-550-07) > 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "64764-0550-07",
"ProductNDC": "64764-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-560-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (64764-560-07) > 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "64764-0560-07",
"ProductNDC": "64764-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-570-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (64764-570-07) > 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "64764-0570-07",
"ProductNDC": "64764-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-580-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (64764-580-07) > 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "64764-0580-07",
"ProductNDC": "64764-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-720-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (64764-720-07) / 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "64764-0720-07",
"ProductNDC": "64764-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131002",
"SamplePackage": "N",
"IndicationAndUsage": "TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)."
},
{
"NDCCode": "64764-730-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (64764-730-07) / 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "64764-0730-07",
"ProductNDC": "64764-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131002",
"SamplePackage": "N",
"IndicationAndUsage": "TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)."
},
{
"NDCCode": "64764-750-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (64764-750-07) / 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "64764-0750-07",
"ProductNDC": "64764-750",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131002",
"SamplePackage": "N",
"IndicationAndUsage": "TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)."
},
{
"NDCCode": "64764-844-07",
"PackageDescription": "5 CARTON in 1 TRAY (64764-844-07) > 1 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "64764-0844-07",
"ProductNDC": "64764-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200796",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "AZILSARTAN KAMEDOXOMIL",
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"StrengthUnit": "mg/1",
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"ProductNdcExcludeFlag": "E",
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{
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{
"NDCCode": "64764-994-07",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ProductNdcExcludeFlag": "N"
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{
"NDCCode": "0944-3940-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-3940-02) * 10 mL in 1 BOTTLE (0944-3941-01) * 10 mL in 1 VIAL, GLASS (64764-516-10) ",
"NDC11Code": "00944-3940-02",
"ProductNDC": "0944-3940",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hemofil M",
"NonProprietaryName": "Antihemophilic Factor Human",
"DosageFormName": "KIT",
"StartMarketingDate": "19880223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101448",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.",
"Description": "HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein [see Clinical Pharmacology]. HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product. Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated.1 The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for viral reduction. These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment, and immunoaffinity chromatography. Introduction of a nanofiltration step with the 0.1µm prefilter and the ASAHI Planova 20N nanofilter provides a virus removal capacity for human immunodeficiency virus, Type 1 (HIV-1), hepatitis A virus (HAV), bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), mice minute virus (MMV), and human parvovirus B19 (B19V) in the order of four (4) logs or higher. B19V removal data were obtained with a Polymerase Chain Reaction (PCR) assay not correlated to an infectivity assay. Studies for nanofiltration and other process steps, summarized in Table 1, demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV."
},
{
"NDCCode": "0944-3942-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-3942-02) * 10 mL in 1 BOTTLE (0944-3943-01) * 10 mL in 1 VIAL, GLASS (64764-516-10) ",
"NDC11Code": "00944-3942-02",
"ProductNDC": "0944-3942",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hemofil M",
"NonProprietaryName": "Antihemophilic Factor Human",
"DosageFormName": "KIT",
"StartMarketingDate": "19880223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101448",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880223",
"SamplePackage": "N",
"IndicationAndUsage": "HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.",
"Description": "HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein [see Clinical Pharmacology]. HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product. Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated.1 The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for viral reduction. These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment, and immunoaffinity chromatography. Introduction of a nanofiltration step with the 0.1µm prefilter and the ASAHI Planova 20N nanofilter provides a virus removal capacity for human immunodeficiency virus, Type 1 (HIV-1), hepatitis A virus (HAV), bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), mice minute virus (MMV), and human parvovirus B19 (B19V) in the order of four (4) logs or higher. B19V removal data were obtained with a Polymerase Chain Reaction (PCR) assay not correlated to an infectivity assay. Studies for nanofiltration and other process steps, summarized in Table 1, demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV."
},
{
"NDCCode": "0944-3944-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-3944-02) * 10 mL in 1 BOTTLE (0944-3945-01) * 10 mL in 1 VIAL, GLASS (64764-516-10) ",
"NDC11Code": "00944-3944-02",
"ProductNDC": "0944-3944",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hemofil M",
"NonProprietaryName": "Antihemophilic Factor Human",
"DosageFormName": "KIT",
"StartMarketingDate": "19880223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101448",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880223",
"SamplePackage": "N",
"IndicationAndUsage": "HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.",
"Description": "HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein [see Clinical Pharmacology]. HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product. Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated.1 The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for viral reduction. These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment, and immunoaffinity chromatography. Introduction of a nanofiltration step with the 0.1µm prefilter and the ASAHI Planova 20N nanofilter provides a virus removal capacity for human immunodeficiency virus, Type 1 (HIV-1), hepatitis A virus (HAV), bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), mice minute virus (MMV), and human parvovirus B19 (B19V) in the order of four (4) logs or higher. B19V removal data were obtained with a Polymerase Chain Reaction (PCR) assay not correlated to an infectivity assay. Studies for nanofiltration and other process steps, summarized in Table 1, demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV."
},
{
"NDCCode": "0944-3946-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-3946-02) * 10 mL in 1 BOTTLE (0944-3947-01) * 10 mL in 1 VIAL, GLASS (64764-516-10) ",
"NDC11Code": "00944-3946-02",
"ProductNDC": "0944-3946",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hemofil M",
"NonProprietaryName": "Antihemophilic Factor Human",
"DosageFormName": "KIT",
"StartMarketingDate": "19880223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101448",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880223",
"SamplePackage": "N",
"IndicationAndUsage": "HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.",
"Description": "HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein [see Clinical Pharmacology]. HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product. Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated.1 The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for viral reduction. These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment, and immunoaffinity chromatography. Introduction of a nanofiltration step with the 0.1µm prefilter and the ASAHI Planova 20N nanofilter provides a virus removal capacity for human immunodeficiency virus, Type 1 (HIV-1), hepatitis A virus (HAV), bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), mice minute virus (MMV), and human parvovirus B19 (B19V) in the order of four (4) logs or higher. B19V removal data were obtained with a Polymerase Chain Reaction (PCR) assay not correlated to an infectivity assay. Studies for nanofiltration and other process steps, summarized in Table 1, demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV."
},
{
"NDCCode": "0944-4622-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4622-01) / 1 CONTAINER in 1 KIT (0944-4622-02) / 1 KIT in 1 CONTAINER (0944-4622-03) * 5 mL in 1 VIAL, GLASS (0944-4137-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
"NDC11Code": "00944-4622-01",
"ProductNDC": "0944-4622",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20160728",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160728",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
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"PackageDescription": "1 KIT in 1 CARTON (0944-4623-01) / 1 CONTAINER in 1 KIT (0944-4623-02) / 1 KIT in 1 CONTAINER (0944-4623-03) * 5 mL in 1 VIAL, GLASS (0944-4138-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
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"ProductNDC": "0944-4623",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
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"DosageFormName": "KIT",
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"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151113",
"SamplePackage": "N",
"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4624-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4624-01) / 1 CONTAINER in 1 KIT (0944-4624-02) / 1 KIT in 1 CONTAINER (0944-4624-03) * 5 mL in 1 VIAL, GLASS (0944-4140-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
"NDC11Code": "00944-4624-01",
"ProductNDC": "0944-4624",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated",
"DosageFormName": "KIT",
"StartMarketingDate": "20161025",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161025",
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"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4625-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4625-01) / 1 CONTAINER in 1 KIT (0944-4625-02) / 1 KIT in 1 CONTAINER (0944-4625-03) * 5 mL in 1 VIAL, GLASS (0944-4257-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
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"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4626-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4626-01) / 1 CONTAINER in 1 KIT (0944-4626-02) / 1 KIT in 1 CONTAINER (0944-4626-03) * 5 mL in 1 VIAL, GLASS (0944-4139-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
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"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4627-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4627-01) / 1 CONTAINER in 1 KIT (0944-4627-02) / 1 KIT in 1 CONTAINER (0944-4627-03) * 5 mL in 1 VIAL, GLASS (0944-4141-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) ",
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"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-4628-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-4628-01) / 1 CONTAINER in 1 KIT (0944-4628-02) / 1 KIT in 1 CONTAINER (0944-4628-03) * 5 mL in 1 VIAL, GLASS (64764-515-50) * 5 mL in 1 VIAL, GLASS (0944-4263-01) ",
"NDC11Code": "00944-4628-01",
"ProductNDC": "0944-4628",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Adynovate",
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"DosageFormName": "KIT",
"StartMarketingDate": "20161025",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125566",
"LabelerName": "Takeda Pharmaceuticals Amercia, Inc.",
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"IndicationAndUsage": "ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins."
},
{
"NDCCode": "0944-7551-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-7551-02) * 5 mL in 1 VIAL, SINGLE-DOSE (0944-7550-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-7551-02",
"ProductNDC": "0944-7551",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Vonvendi",
"NonProprietaryName": "Von Willebrand Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20151208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125577",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151208",
"SamplePackage": "N",
"IndicationAndUsage": "VONVENDI® is indicated in adult and pediatric patients with von Willebrand disease (VWD) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management of bleeding.",
"Description": "VONVENDI is a purified rVWF expressed in Chinese Hamster Ovary (CHO) cells. VONVENDI is produced and formulated without the addition of any exogenous raw materials of human or animal origin in the cell culture, purification, or formulation of the final product. Proteins present in the final container product other than rVWF are trace quantities of mouse immunoglobulin (IgG, from the immunoaffinity purification), host cell (i.e., CHO) protein, rFurin (used to further process rVWF), and recombinant factor VIII (rFVIII). Von Willebrand factor is a large multimeric glycoprotein that is normally found in plasma, and stored as ultra-large multimers in alpha-granules of platelets and intracellular organelles known as Weibel-Palade bodies, prior to secretion into the blood.1 Once the VWF is released to the blood stream and in contact with ADAMTS13 (a proteolytic enzyme in blood), it is cleaved to smaller sizes that can be detected with SDS agarose gels as multimer bands, representing the various species of VWF within the circulation. VONVENDI is rVWF that contains ultra-large multimers in addition to all of the multimers found in plasma as it is not exposed to proteolysis by ADAMTS13 during the manufacturing process. VONVENDI is formulated as a sterile, non-pyrogenic, white to off-white friable powder for intravenous injection after reconstitution. VONVENDI in a single-dose vial contains nominally 650 or 1300 IU VWF:RCo. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection the final solution contains the following stabilizers and excipients (Table 6) in targeted amounts. Each vial of VONVENDI is labeled with the specific number of units of VWF:RCo expressed in IU, which are based on the current World Health Organization (WHO) standard for VWF concentrate. After reconstitution of the lyophilized powder and filtration/withdrawal into a syringe, all dosage strengths yield a clear, colorless solution, free from particles."
}
]
}
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<PackageDescription>5 CARTON in 1 TRAY (64764-944-07) > 1 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0944-07</NDC11Code>
<ProductNDC>64764-944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Edarbyclor</ProprietaryName>
<NonProprietaryName>Azilsartan Medoxomil And Chlorthalidone</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20111223</StartMarketingDate>
<EndMarketingDate>20180501</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>40; 12.5</StrengthNumber>
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<Pharm_Classes>Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<PackageDescription>7 TABLET in 1 BLISTER PACK (67046-944-07)</PackageDescription>
<NDC11Code>67046-0944-07</NDC11Code>
<ProductNDC>67046-944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071322</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diazepam Tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam Tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Diazepam Tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C 16H 13ClN 2O M.W. 284.75. Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
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<NDCCode>64764-944-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64764-944-30)</PackageDescription>
<NDC11Code>64764-0944-30</NDC11Code>
<ProductNDC>64764-944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Edarbyclor</ProprietaryName>
<NonProprietaryName>Azilsartan Medoxomil And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111223</StartMarketingDate>
<EndMarketingDate>20180501</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202331</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>40; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>64764-944-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (64764-944-90)</PackageDescription>
<NDC11Code>64764-0944-90</NDC11Code>
<ProductNDC>64764-944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Edarbyclor</ProprietaryName>
<NonProprietaryName>Azilsartan Medoxomil And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111223</StartMarketingDate>
<EndMarketingDate>20180501</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202331</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>40; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0944-2656-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2656-03) * 96 mL in 1 BOTTLE (0338-0001-77) * 96 mL in 1 BOTTLE (64764-512-96) * 100 mL in 1 BOTTLE (0944-2657-07) </PackageDescription>
<NDC11Code>00944-2656-03</NDC11Code>
<ProductNDC>0944-2656</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard</ProprietaryName>
<ProprietaryNameSuffix>S/d</ProprietaryNameSuffix>
<NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19940510</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103133</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAMMAGARD S/D is an Immune Globulin Intravenous (Human) indicated for: 1 Treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age or older. (1), 2 Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL). (1), 3 Prevention and/or control of bleeding in adult chronic idiopathic thrombocytopenic purpura (ITP) patients. (1), 4 Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. (1).</IndicationAndUsage>
<Description>GAMMAGARD S/D, Immune Globulin Intravenous (Human), IgA less than 1 µg/mL in a 5% Solution (IgA < 1 µg/mL), is GAMMAGARD S/D selected to have an IgA concentration of less than 1 µg/mL of IgA in a 5% solution. GAMMAGARD S/D is a solvent/detergent treated, sterile, freeze-dried preparation of purified immunoglobulin G (IgG) derived from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography steps. The distribution of IgG subclasses present in this product is similar to that in normal plasma. The Fc portion is maintained intact. When reconstituted with the total volume of diluent (Sterile Water for Injection, USP) supplied and reconstituted to 5% solution, the product contains approximately 50 mg/mL of protein, of which at least 90% is gamma globulin. GAMMAGARD S/D contains < 1 µg/mL of IgA in a 5% solution and IgM is present in trace amounts. GAMMAGARD S/D contains all of the IgG antibody activities which are present in the donor population. The product, after reconstituted to 5% solution, contains a physiological concentration of sodium chloride (approximately 8.5 mg/mL) and has a pH of 6.8 ± 0.4. Stabilizing agents and additional components are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin (Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG), 1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100 µg/mL polysorbate 80. GAMMAGARD S/D contains no preservative. To prepare a 10% (100 mg/mL) solution for infusion, add half the volume of diluent, as described in Dosage and Administration (2.1). The content of the stabilizing agents and other components, including IgA, for the 10% solution will be doubled compared to the 5% solution. Screening against potentially infectious agents in the product begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of GAMMAGARD S/D is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (HIV-1/HIV-2) and hepatitis C virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed nucleic acid testing (NAT) and found negative. The manufacturing process includes treatment with an organic solvent/detergent mixture12,13, composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80. The GAMMAGARD S/D manufacturing process provides for viral reduction in in vitro studies. These studies, summarized in Table 6 demonstrate virus clearance during GAMMAGARD S/D manufacturing using human immunodeficiency virus, Type 1 (HIV-1), as the relevant virus and model for HIV-2; bovine viral diarrhea virus (BVDV), a model virus for enveloped RNA viruses such as hepatitis C virus (HCV); pseudorabies virus (PRV), a generic model virus for enveloped DNA viruses such as hepatitis B virus (HBV); encephalomyocarditis virus (EMCV), a model for non-enveloped RNA viruses such as hepatitis A virus (HAV); HAV; and mice minute virus (MMV), a model for small non-enveloped DNA viruses such as human parvovirus B19 (B19V). These reductions are achieved through partitioning and inactivation during cold ethanol fractionation, and the solvent/detergent treatment.</Description>
</NDC>
<NDC>
<NDCCode>64764-119-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-07) </PackageDescription>
<NDC11Code>64764-0119-07</NDC11Code>
<ProductNDC>64764-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colcrys</ProprietaryName>
<NonProprietaryName>Colchicine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022352</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COLCRYS (colchicine, USP) is an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1)., 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).</IndicationAndUsage>
<Description>Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine occurs as a pale yellow powder that is soluble in water. COLCRYS (colchicine, USP) tablets are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575" × 0.3030"), debossed with "AR 374" on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>64764-310-07</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64764-310-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0310-07</NDC11Code>
<ProductNDC>64764-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actoplus Met</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Pioglitazone And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100611</StartMarketingDate>
<EndMarketingDate>20220930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022024</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100611</StartMarketingDatePackage>
<EndMarketingDatePackage>20220930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64764-510-07</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64764-510-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0510-07</NDC11Code>
<ProductNDC>64764-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actoplus Met</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Pioglitazone And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100611</StartMarketingDate>
<EndMarketingDate>20220930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022024</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100611</StartMarketingDatePackage>
<EndMarketingDatePackage>20220930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64764-550-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64764-550-07) > 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>64764-0550-07</NDC11Code>
<ProductNDC>64764-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-560-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64764-560-07) > 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>64764-0560-07</NDC11Code>
<ProductNDC>64764-560</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-570-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64764-570-07) > 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>64764-0570-07</NDC11Code>
<ProductNDC>64764-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-580-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64764-580-07) > 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>64764-0580-07</NDC11Code>
<ProductNDC>64764-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-720-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64764-720-07) / 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>64764-0720-07</NDC11Code>
<ProductNDC>64764-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>64764-730-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64764-730-07) / 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>64764-0730-07</NDC11Code>
<ProductNDC>64764-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>64764-750-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64764-750-07) / 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>64764-0750-07</NDC11Code>
<ProductNDC>64764-750</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>64764-844-07</NDCCode>
<PackageDescription>5 CARTON in 1 TRAY (64764-844-07) > 1 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0844-07</NDC11Code>
<ProductNDC>64764-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Edarbi</ProprietaryName>
<NonProprietaryName>Azilsartan Kamedoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110225</StartMarketingDate>
<EndMarketingDate>20180201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200796</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-884-07</NDCCode>
<PackageDescription>5 CARTON in 1 TRAY (64764-884-07) > 1 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0884-07</NDC11Code>
<ProductNDC>64764-884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Edarbi</ProprietaryName>
<NonProprietaryName>Azilsartan Kamedoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110225</StartMarketingDate>
<EndMarketingDate>20180201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200796</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-994-07</NDCCode>
<PackageDescription>5 CARTON in 1 TRAY (64764-994-07) > 1 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0994-07</NDC11Code>
<ProductNDC>64764-994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Edarbyclor</ProprietaryName>
<NonProprietaryName>Azilsartan Medoxomil And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111223</StartMarketingDate>
<EndMarketingDate>20180501</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202331</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>40; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0944-3940-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-3940-02) * 10 mL in 1 BOTTLE (0944-3941-01) * 10 mL in 1 VIAL, GLASS (64764-516-10) </PackageDescription>
<NDC11Code>00944-3940-02</NDC11Code>
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<IndicationAndUsage>HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein [see Clinical Pharmacology]. HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product. Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated.1 The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for viral reduction. These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment, and immunoaffinity chromatography. Introduction of a nanofiltration step with the 0.1µm prefilter and the ASAHI Planova 20N nanofilter provides a virus removal capacity for human immunodeficiency virus, Type 1 (HIV-1), hepatitis A virus (HAV), bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), mice minute virus (MMV), and human parvovirus B19 (B19V) in the order of four (4) logs or higher. B19V removal data were obtained with a Polymerase Chain Reaction (PCR) assay not correlated to an infectivity assay. Studies for nanofiltration and other process steps, summarized in Table 1, demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV.</Description>
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<IndicationAndUsage>HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein [see Clinical Pharmacology]. HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product. Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated.1 The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for viral reduction. These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment, and immunoaffinity chromatography. Introduction of a nanofiltration step with the 0.1µm prefilter and the ASAHI Planova 20N nanofilter provides a virus removal capacity for human immunodeficiency virus, Type 1 (HIV-1), hepatitis A virus (HAV), bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), mice minute virus (MMV), and human parvovirus B19 (B19V) in the order of four (4) logs or higher. B19V removal data were obtained with a Polymerase Chain Reaction (PCR) assay not correlated to an infectivity assay. Studies for nanofiltration and other process steps, summarized in Table 1, demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV.</Description>
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<IndicationAndUsage>HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein [see Clinical Pharmacology]. HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product. Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated.1 The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for viral reduction. These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment, and immunoaffinity chromatography. Introduction of a nanofiltration step with the 0.1µm prefilter and the ASAHI Planova 20N nanofilter provides a virus removal capacity for human immunodeficiency virus, Type 1 (HIV-1), hepatitis A virus (HAV), bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), mice minute virus (MMV), and human parvovirus B19 (B19V) in the order of four (4) logs or higher. B19V removal data were obtained with a Polymerase Chain Reaction (PCR) assay not correlated to an infectivity assay. Studies for nanofiltration and other process steps, summarized in Table 1, demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV.</Description>
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<IndicationAndUsage>HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein [see Clinical Pharmacology]. HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product. Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated.1 The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for viral reduction. These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment, and immunoaffinity chromatography. Introduction of a nanofiltration step with the 0.1µm prefilter and the ASAHI Planova 20N nanofilter provides a virus removal capacity for human immunodeficiency virus, Type 1 (HIV-1), hepatitis A virus (HAV), bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), mice minute virus (MMV), and human parvovirus B19 (B19V) in the order of four (4) logs or higher. B19V removal data were obtained with a Polymerase Chain Reaction (PCR) assay not correlated to an infectivity assay. Studies for nanofiltration and other process steps, summarized in Table 1, demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV.</Description>
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<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
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<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
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<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
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<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
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<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
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<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
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<NDCCode>0944-4628-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-4628-01) / 1 CONTAINER in 1 KIT (0944-4628-02) / 1 KIT in 1 CONTAINER (0944-4628-03) * 5 mL in 1 VIAL, GLASS (64764-515-50) * 5 mL in 1 VIAL, GLASS (0944-4263-01) </PackageDescription>
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<IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
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<NDC>
<NDCCode>0944-7551-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-7551-02) * 5 mL in 1 VIAL, SINGLE-DOSE (0944-7550-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-7551-02</NDC11Code>
<ProductNDC>0944-7551</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Vonvendi</ProprietaryName>
<NonProprietaryName>Von Willebrand Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125577</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
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<IndicationAndUsage>VONVENDI® is indicated in adult and pediatric patients with von Willebrand disease (VWD) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management of bleeding.</IndicationAndUsage>
<Description>VONVENDI is a purified rVWF expressed in Chinese Hamster Ovary (CHO) cells. VONVENDI is produced and formulated without the addition of any exogenous raw materials of human or animal origin in the cell culture, purification, or formulation of the final product. Proteins present in the final container product other than rVWF are trace quantities of mouse immunoglobulin (IgG, from the immunoaffinity purification), host cell (i.e., CHO) protein, rFurin (used to further process rVWF), and recombinant factor VIII (rFVIII). Von Willebrand factor is a large multimeric glycoprotein that is normally found in plasma, and stored as ultra-large multimers in alpha-granules of platelets and intracellular organelles known as Weibel-Palade bodies, prior to secretion into the blood.1 Once the VWF is released to the blood stream and in contact with ADAMTS13 (a proteolytic enzyme in blood), it is cleaved to smaller sizes that can be detected with SDS agarose gels as multimer bands, representing the various species of VWF within the circulation. VONVENDI is rVWF that contains ultra-large multimers in addition to all of the multimers found in plasma as it is not exposed to proteolysis by ADAMTS13 during the manufacturing process. VONVENDI is formulated as a sterile, non-pyrogenic, white to off-white friable powder for intravenous injection after reconstitution. VONVENDI in a single-dose vial contains nominally 650 or 1300 IU VWF:RCo. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection the final solution contains the following stabilizers and excipients (Table 6) in targeted amounts. Each vial of VONVENDI is labeled with the specific number of units of VWF:RCo expressed in IU, which are based on the current World Health Organization (WHO) standard for VWF concentrate. After reconstitution of the lyophilized powder and filtration/withdrawal into a syringe, all dosage strengths yield a clear, colorless solution, free from particles.</Description>
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