{
"NDC": [
{
"NDCCode": "70748-332-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (70748-332-04) / 15 mL in 1 BOTTLE",
"NDC11Code": "70748-0332-04",
"ProductNDC": "70748-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Acetate",
"NonProprietaryName": "Prednisolone Acetate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216935",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "PREDNISOLONE ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.",
"Description": "Prednisolone acetate ophthalmic suspension USP, 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure:. Each mL of prednisolone acetate ophthalmic suspension USP contains:. Active: prednisolone acetate (micronized) 1%. Inactive: benzalkonium chloride as preservative, boric acid, edetate disodium, hypromellose, polysorbate 80, sodium bisulfite, sodium chloride, sodium citrate and water for injection. The pH during its shelf life ranges from 5.0 to 6.0."
},
{
"NDCCode": "70748-257-60",
"PackageDescription": "15 POUCH in 1 CARTON (70748-257-60) / 4 VIAL, SINGLE-DOSE in 1 POUCH (70748-257-04) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "70748-0257-60",
"ProductNDC": "70748-257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arformoterol Tartrate",
"NonProprietaryName": "Arformoterol Tartrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210601",
"EndMarketingDate": "20231130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021912",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ARFORMOTEROL TARTRATE",
"StrengthNumber": "15",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210601",
"EndMarketingDatePackage": "20231130",
"SamplePackage": "N"
},
{
"NDCCode": "70748-332-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (70748-332-02) / 5 mL in 1 BOTTLE",
"NDC11Code": "70748-0332-02",
"ProductNDC": "70748-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Acetate",
"NonProprietaryName": "Prednisolone Acetate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216935",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "PREDNISOLONE ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.",
"Description": "Prednisolone acetate ophthalmic suspension USP, 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure:. Each mL of prednisolone acetate ophthalmic suspension USP contains:. Active: prednisolone acetate (micronized) 1%. Inactive: benzalkonium chloride as preservative, boric acid, edetate disodium, hypromellose, polysorbate 80, sodium bisulfite, sodium chloride, sodium citrate and water for injection. The pH during its shelf life ranges from 5.0 to 6.0."
},
{
"NDCCode": "70748-332-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (70748-332-03) / 10 mL in 1 BOTTLE",
"NDC11Code": "70748-0332-03",
"ProductNDC": "70748-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Acetate",
"NonProprietaryName": "Prednisolone Acetate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216935",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "PREDNISOLONE ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.",
"Description": "Prednisolone acetate ophthalmic suspension USP, 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure:. Each mL of prednisolone acetate ophthalmic suspension USP contains:. Active: prednisolone acetate (micronized) 1%. Inactive: benzalkonium chloride as preservative, boric acid, edetate disodium, hypromellose, polysorbate 80, sodium bisulfite, sodium chloride, sodium citrate and water for injection. The pH during its shelf life ranges from 5.0 to 6.0."
},
{
"NDCCode": "11673-332-04",
"PackageDescription": "113.3 g in 1 TUBE (11673-332-04)",
"NDC11Code": "11673-0332-04",
"ProductNDC": "11673-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up",
"ProprietaryNameSuffix": "Creamy Diaper Rash",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN DUE TO DIAPER RASH. HELPS SEAL OUT WETNESS."
},
{
"NDCCode": "52125-332-04",
"PackageDescription": "14 TABLET in 1 VIAL (52125-332-04)",
"NDC11Code": "52125-0332-04",
"ProductNDC": "52125-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077829",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "57881-332-32",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (57881-332-32) > 4 TABLET in 1 BLISTER PACK (57881-332-04)",
"NDC11Code": "57881-0332-32",
"ProductNDC": "57881-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abstral",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20130808",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022510",
"LabelerName": "Galena Biopharma, Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-theclock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL. ABSTRAL is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, ABSTRAL is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. ABSTRAL is intended to be prescribed only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain. Limitations of Use:. As a part of the TIRF REMS Access program, ABSTRAL may be dispensed only to outpatients enrolled in the program [see Warnings and Precautions (5.10)]. For inpatient administration of ABSTRAL (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.",
"Description": "ABSTRAL (fentanyl) sublingual tablet is a solid formulation of fentanyl citrate, a potent opioid analgesic intended for oral sublingual administration. ABSTRAL is formulated as a white tablet available in six strengths, distinguishable by the shape of the tablet and by de-bossing on the tablet surface. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula:. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 mcg strength tablet contains 100 mcg of fentanyl free base. Inactive Ingredients: Croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose."
},
{
"NDCCode": "63545-332-04",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-332-04) ",
"NDC11Code": "63545-0332-04",
"ProductNDC": "63545-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bromoethanum",
"NonProprietaryName": "Bromoethanum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220510",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BROMOETHANE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220510",
"SamplePackage": "N"
},
{
"NDCCode": "65219-554-08",
"PackageDescription": "1 KIT in 1 CARTON (65219-554-08) * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) ",
"NDC11Code": "65219-0554-08",
"ProductNDC": "65219-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Idacio",
"NonProprietaryName": "Adalimumab-aacf",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761255",
"LabelerName": "Fresenius Kabi USA, LLC",
"Status": "Deprecated",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "IDACIO is a tumor necrosis factor (TNF) blocker indicated for: : 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. , 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. , 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. , 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS. , 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. , 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients. , 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. , 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients. , 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. .",
"Description": "Adalimumab-aacf is a tumor necrosis factor blocker. Adalimumab-aacf is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aacf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. IDACIO (adalimumab-aacf) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (IDACIO Pen), as a single-dose, 1 mL or prefilled glass syringe or as a single dose institutional use vial kit. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of IDACIO is clear and colorless to pale yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen, or institutional use vial kit delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of IDACIO contains adalimumab-aacf (40 mg) and glacial acetic acid (0.5 mg), trehalose (54.8 mg), polysorbate 80 (0.8 mg), sodium chloride (2.3 mg), and Water for Injection. Sodium hydroxide is added to adjust pH."
},
{
"NDCCode": "65219-554-28",
"PackageDescription": "2 KIT in 1 CARTON (65219-554-28) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) ",
"NDC11Code": "65219-0554-28",
"ProductNDC": "65219-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Idacio",
"NonProprietaryName": "Adalimumab-aacf",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761255",
"LabelerName": "Fresenius Kabi USA, LLC",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "IDACIO is a tumor necrosis factor (TNF) blocker indicated for: : 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. , 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. , 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. , 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS. , 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. , 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients. , 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. , 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients. , 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. .",
"Description": "Adalimumab-aacf is a tumor necrosis factor blocker. Adalimumab-aacf is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aacf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. IDACIO (adalimumab-aacf) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (IDACIO Pen), as a single-dose, 1 mL or prefilled glass syringe or as a single dose institutional use vial kit. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of IDACIO is clear and colorless to pale yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen, or institutional use vial kit delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of IDACIO contains adalimumab-aacf (40 mg) and glacial acetic acid (0.5 mg), trehalose (54.8 mg), polysorbate 80 (0.8 mg), sodium chloride (2.3 mg), and Water for Injection. Sodium hydroxide is added to adjust pH."
},
{
"NDCCode": "65219-554-38",
"PackageDescription": "3 KIT in 1 CARTON (65219-554-38) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) ",
"NDC11Code": "65219-0554-38",
"ProductNDC": "65219-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Idacio",
"NonProprietaryName": "Adalimumab-aacf",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761255",
"LabelerName": "Fresenius Kabi USA, LLC",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "IDACIO is a tumor necrosis factor (TNF) blocker indicated for: : 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. , 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. , 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. , 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS. , 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. , 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients. , 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. , 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients. , 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. .",
"Description": "Adalimumab-aacf is a tumor necrosis factor blocker. Adalimumab-aacf is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aacf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. IDACIO (adalimumab-aacf) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (IDACIO Pen), as a single-dose, 1 mL or prefilled glass syringe or as a single dose institutional use vial kit. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of IDACIO is clear and colorless to pale yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen, or institutional use vial kit delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of IDACIO contains adalimumab-aacf (40 mg) and glacial acetic acid (0.5 mg), trehalose (54.8 mg), polysorbate 80 (0.8 mg), sodium chloride (2.3 mg), and Water for Injection. Sodium hydroxide is added to adjust pH."
},
{
"NDCCode": "75366-332-04",
"PackageDescription": "1892.7 mL in 1 BOTTLE, PUMP (75366-332-04) ",
"NDC11Code": "75366-0332-04",
"ProductNDC": "75366-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Citrus Scent",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200610",
"EndMarketingDate": "20210805",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Clearbrooke Technologies LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200610",
"EndMarketingDatePackage": "20210805",
"SamplePackage": "N"
},
{
"NDCCode": "75682-332-04",
"PackageDescription": "118.294 mL in 1 BOTTLE, PUMP (75682-332-04) ",
"NDC11Code": "75682-0332-04",
"ProductNDC": "75682-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply 62 Hand Sanitizer Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Froggy's Fog LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77282-332-04",
"PackageDescription": "118 mL in 1 BOTTLE (77282-332-04) ",
"NDC11Code": "77282-0332-04",
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"ProductTypeName": "HUMAN OTC DRUG",
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"Description": "ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF 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 rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, 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. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein."
},
{
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"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) ",
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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."
},
{
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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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"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) ",
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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": "0944-4625-01",
"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) ",
"NDC11Code": "00944-4625-01",
"ProductNDC": "0944-4625",
"ProductTypeName": "PLASMA DERIVATIVE",
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"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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"ProductTypeName": "PLASMA DERIVATIVE",
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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."
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"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."
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<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.</IndicationAndUsage>
<Description>Prednisolone acetate ophthalmic suspension USP, 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure:. Each mL of prednisolone acetate ophthalmic suspension USP contains:. Active: prednisolone acetate (micronized) 1%. Inactive: benzalkonium chloride as preservative, boric acid, edetate disodium, hypromellose, polysorbate 80, sodium bisulfite, sodium chloride, sodium citrate and water for injection. The pH during its shelf life ranges from 5.0 to 6.0.</Description>
</NDC>
<NDC>
<NDCCode>11673-332-04</NDCCode>
<PackageDescription>113.3 g in 1 TUBE (11673-332-04)</PackageDescription>
<NDC11Code>11673-0332-04</NDC11Code>
<ProductNDC>11673-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up</ProprietaryName>
<ProprietaryNameSuffix>Creamy Diaper Rash</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN DUE TO DIAPER RASH. HELPS SEAL OUT WETNESS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52125-332-04</NDCCode>
<PackageDescription>14 TABLET in 1 VIAL (52125-332-04)</PackageDescription>
<NDC11Code>52125-0332-04</NDC11Code>
<ProductNDC>52125-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077829</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>57881-332-32</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (57881-332-32) > 4 TABLET in 1 BLISTER PACK (57881-332-04)</PackageDescription>
<NDC11Code>57881-0332-32</NDC11Code>
<ProductNDC>57881-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abstral</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20130808</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022510</ApplicationNumber>
<LabelerName>Galena Biopharma, Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-theclock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL. ABSTRAL is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, ABSTRAL is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. ABSTRAL is intended to be prescribed only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain. Limitations of Use:. As a part of the TIRF REMS Access program, ABSTRAL may be dispensed only to outpatients enrolled in the program [see Warnings and Precautions (5.10)]. For inpatient administration of ABSTRAL (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.</IndicationAndUsage>
<Description>ABSTRAL (fentanyl) sublingual tablet is a solid formulation of fentanyl citrate, a potent opioid analgesic intended for oral sublingual administration. ABSTRAL is formulated as a white tablet available in six strengths, distinguishable by the shape of the tablet and by de-bossing on the tablet surface. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula:. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 mcg strength tablet contains 100 mcg of fentanyl free base. Inactive Ingredients: Croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>63545-332-04</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (63545-332-04) </PackageDescription>
<NDC11Code>63545-0332-04</NDC11Code>
<ProductNDC>63545-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bromoethanum</ProprietaryName>
<NonProprietaryName>Bromoethanum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220510</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BROMOETHANE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65219-554-08</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (65219-554-08) * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) </PackageDescription>
<NDC11Code>65219-0554-08</NDC11Code>
<ProductNDC>65219-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Idacio</ProprietaryName>
<NonProprietaryName>Adalimumab-aacf</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761255</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IDACIO is a tumor necrosis factor (TNF) blocker indicated for: : 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. , 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. , 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. , 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS. , 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. , 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients. , 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. , 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients. , 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. .</IndicationAndUsage>
<Description>Adalimumab-aacf is a tumor necrosis factor blocker. Adalimumab-aacf is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aacf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. IDACIO (adalimumab-aacf) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (IDACIO Pen), as a single-dose, 1 mL or prefilled glass syringe or as a single dose institutional use vial kit. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of IDACIO is clear and colorless to pale yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen, or institutional use vial kit delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of IDACIO contains adalimumab-aacf (40 mg) and glacial acetic acid (0.5 mg), trehalose (54.8 mg), polysorbate 80 (0.8 mg), sodium chloride (2.3 mg), and Water for Injection. Sodium hydroxide is added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>65219-554-28</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (65219-554-28) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) </PackageDescription>
<NDC11Code>65219-0554-28</NDC11Code>
<ProductNDC>65219-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Idacio</ProprietaryName>
<NonProprietaryName>Adalimumab-aacf</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761255</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IDACIO is a tumor necrosis factor (TNF) blocker indicated for: : 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. , 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. , 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. , 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS. , 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. , 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients. , 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. , 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients. , 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. .</IndicationAndUsage>
<Description>Adalimumab-aacf is a tumor necrosis factor blocker. Adalimumab-aacf is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aacf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. IDACIO (adalimumab-aacf) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (IDACIO Pen), as a single-dose, 1 mL or prefilled glass syringe or as a single dose institutional use vial kit. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of IDACIO is clear and colorless to pale yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen, or institutional use vial kit delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of IDACIO contains adalimumab-aacf (40 mg) and glacial acetic acid (0.5 mg), trehalose (54.8 mg), polysorbate 80 (0.8 mg), sodium chloride (2.3 mg), and Water for Injection. Sodium hydroxide is added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>65219-554-38</NDCCode>
<PackageDescription>3 KIT in 1 CARTON (65219-554-38) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) </PackageDescription>
<NDC11Code>65219-0554-38</NDC11Code>
<ProductNDC>65219-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Idacio</ProprietaryName>
<NonProprietaryName>Adalimumab-aacf</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761255</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IDACIO is a tumor necrosis factor (TNF) blocker indicated for: : 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. , 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. , 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. , 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS. , 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. , 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients. , 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. , 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients. , 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. .</IndicationAndUsage>
<Description>Adalimumab-aacf is a tumor necrosis factor blocker. Adalimumab-aacf is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aacf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. IDACIO (adalimumab-aacf) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (IDACIO Pen), as a single-dose, 1 mL or prefilled glass syringe or as a single dose institutional use vial kit. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of IDACIO is clear and colorless to pale yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen, or institutional use vial kit delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of IDACIO contains adalimumab-aacf (40 mg) and glacial acetic acid (0.5 mg), trehalose (54.8 mg), polysorbate 80 (0.8 mg), sodium chloride (2.3 mg), and Water for Injection. Sodium hydroxide is added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>75366-332-04</NDCCode>
<PackageDescription>1892.7 mL in 1 BOTTLE, PUMP (75366-332-04) </PackageDescription>
<NDC11Code>75366-0332-04</NDC11Code>
<ProductNDC>75366-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Citrus Scent</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200610</StartMarketingDate>
<EndMarketingDate>20210805</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Clearbrooke Technologies LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<EndMarketingDatePackage>20210805</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75682-332-04</NDCCode>
<PackageDescription>118.294 mL in 1 BOTTLE, PUMP (75682-332-04) </PackageDescription>
<NDC11Code>75682-0332-04</NDC11Code>
<ProductNDC>75682-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply 62 Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Froggy's Fog LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77282-332-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (77282-332-04) </PackageDescription>
<NDC11Code>77282-0332-04</NDC11Code>
<ProductNDC>77282-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Sustainable Tech LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-332-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (83324-332-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>83324-0332-04</NDC11Code>
<ProductNDC>83324-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice</ProprietaryName>
<ProprietaryNameSuffix>Adult Tussin Expectorant</ProprietaryNameSuffix>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250905</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-332-04</NDCCode>
<PackageDescription>50 g in 1 BOX (84756-332-04) </PackageDescription>
<NDC11Code>84756-0332-04</NDC11Code>
<ProductNDC>84756-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Retinol Cream</ProprietaryName>
<NonProprietaryName>Trstay Retinol Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
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<IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF 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 rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, 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. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
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<IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF 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 rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, 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. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
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<IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF 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 rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, 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. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
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<IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF 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 rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, 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. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
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<IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF 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 rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, 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. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
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<IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF 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 rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, 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. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
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<IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF 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 rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, 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. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</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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<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) </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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<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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