{
"NDC": [
{
"NDCCode": "15054-0010-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (15054-0010-1) / 14 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "15054-0010-01",
"ProductNDC": "15054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sohonos",
"NonProprietaryName": "Palovarotene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215559",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "PALOVAROTENE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230816",
"SamplePackage": "N",
"IndicationAndUsage": "SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).",
"Description": "Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac."
},
{
"NDCCode": "15054-0015-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (15054-0015-1) / 14 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "15054-0015-01",
"ProductNDC": "15054-0015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sohonos",
"NonProprietaryName": "Palovarotene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215559",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "PALOVAROTENE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230816",
"SamplePackage": "N",
"IndicationAndUsage": "SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).",
"Description": "Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac."
},
{
"NDCCode": "15054-0025-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (15054-0025-1) / 14 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "15054-0025-01",
"ProductNDC": "15054-0025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sohonos",
"NonProprietaryName": "Palovarotene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230816",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215559",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "PALOVAROTENE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230816",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).",
"Description": "Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac."
},
{
"NDCCode": "15054-0043-1",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "15054-0043-01",
"ProductNDC": "15054-0043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Onivyde",
"NonProprietaryName": "Irinotecan Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207793",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "IRINOTECAN HYDROCHLORIDE",
"StrengthNumber": "4.3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151022",
"SamplePackage": "N",
"IndicationAndUsage": "ONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.",
"Description": "ONIVYDE is formulated with irinotecan hydrochloride trihydrate, a topoisomerase inhibitor, into a liposomal dispersion for intravenous use. The chemical name of irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate. The empirical formula is C33H38N4O6∙HCl∙3H2O and the molecular weight is 677.19 g/mole. The molecular structure is. ONIVYDE is a sterile, white to slightly yellow opaque isotonic liposomal dispersion. Each 10 mL single-dose vial contains 43 mg irinotecan free base at a concentration of 4.3 mg/mL. The liposome is a unilamellar lipid bilayer vesicle, approximately 110 nm in diameter, which encapsulates an aqueous space containing irinotecan in a gelated or precipitated state as the sucrose octasulfate salt. The vesicle is composed of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) 6.81 mg/mL, cholesterol 2.22 mg/mL, and methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidyl ethanolamine (MPEG-2000-DSPE) 0.12 mg/mL. Each mL also contains 2-[4-(2-hydroxyethyl) piperazin-1-yl]ethanesulfonic acid (HEPES) as a buffer 4.05 mg/mL and sodium chloride as an isotonicity reagent 8.42 mg/mL."
},
{
"NDCCode": "15054-0050-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (15054-0050-1) / 14 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "15054-0050-01",
"ProductNDC": "15054-0050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sohonos",
"NonProprietaryName": "Palovarotene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215559",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "PALOVAROTENE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230816",
"SamplePackage": "N",
"IndicationAndUsage": "SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).",
"Description": "Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac."
},
{
"NDCCode": "15054-0060-1",
"PackageDescription": "1 POUCH in 1 CARTON (15054-0060-1) > 1 SYRINGE in 1 POUCH > .2 mL in 1 SYRINGE",
"NDC11Code": "15054-0060-01",
"ProductNDC": "15054-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "15054-0080-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "15054-0080-01",
"ProductNDC": "15054-0080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iqirvo",
"NonProprietaryName": "Elafibranor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218860",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "ELAFIBRANOR",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inducers [MoA], Peroxisome Proliferator-activated Receptor Agonist [EPC], Peroxisome Proliferator-activated Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "IQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP) [see Clinical Studies (14)]. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists. Elafibranor is practically insoluble in aqueous media at pH in the range 1.2 to 6.8. It is very slightly soluble at pH 7.5. It is soluble in dichloromethane, freely soluble in DMSO and sparingly soluble in 2-propanol and ethanol. Its chemical formula is C22H24O4S, the molecular weight is 384.49 g/mol, the chemical name is 2-(2,6-Dimethyl-4-{3-[4-(methylsulfanyl)phenyl]-3-oxoprop-1-en-1-yl}phenoxy)-2-methylpropanoic acid and it has the following structural formula. IQIRVO (elafibranor) tablets are supplied as 80 mg film-coated tablets for oral administration. Each tablet contains 80 mg elafibranor and the following inactive ingredients: colloidal silica dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone. The film coating consists of: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "15054-0090-1",
"PackageDescription": "1 POUCH in 1 CARTON (15054-0090-1) > 1 SYRINGE in 1 POUCH > .3 mL in 1 SYRINGE",
"NDC11Code": "15054-0090-01",
"ProductNDC": "15054-0090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "90",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "15054-0100-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (15054-0100-1) / 14 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "15054-0100-01",
"ProductNDC": "15054-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sohonos",
"NonProprietaryName": "Palovarotene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215559",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "PALOVAROTENE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230816",
"SamplePackage": "N",
"IndicationAndUsage": "SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).",
"Description": "Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac."
},
{
"NDCCode": "15054-0120-1",
"PackageDescription": "1 POUCH in 1 CARTON (15054-0120-1) > 1 SYRINGE in 1 POUCH > .5 mL in 1 SYRINGE",
"NDC11Code": "15054-0120-01",
"ProductNDC": "15054-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "120",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "15054-0211-5",
"PackageDescription": "5 CARTRIDGE in 1 CARTON (15054-0211-5) > 3 mL in 1 CARTRIDGE (15054-0211-1)",
"NDC11Code": "15054-0211-05",
"ProductNDC": "15054-0211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apokyn",
"NonProprietaryName": "Apomorphine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040702",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021264",
"LabelerName": "Tercica, Inc.",
"SubstanceName": "APOMORPHINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "15054-0500-1",
"PackageDescription": "1 VIAL in 1 CARTON (15054-0500-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "15054-0500-01",
"ProductNDC": "15054-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dysport",
"NonProprietaryName": "Botulinum Toxin Type A",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20091102",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125274",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "BOTULINUM TOXIN TYPE A",
"StrengthNumber": "500",
"StrengthUnit": "U/1",
"Pharm_Classes": "Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091102",
"SamplePackage": "N",
"IndicationAndUsage": "DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 The treatment of cervical dystonia in adults (1.1), 2 The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2), 3 The treatment of spasticity in patients 2 years of age and older (1.3).",
"Description": "Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein. DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [see Contraindications (4) and Warnings and Precautions (5.3)]. The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. Due to specific details of the assay system, such as vehicle, dilution scheme and laboratory protocols, Units of biological activity of DYSPORT cannot be converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method."
},
{
"NDCCode": "15054-0500-2",
"PackageDescription": "2 VIAL in 1 CARTON (15054-0500-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "15054-0500-02",
"ProductNDC": "15054-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dysport",
"NonProprietaryName": "Botulinum Toxin Type A",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20091102",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125274",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "BOTULINUM TOXIN TYPE A",
"StrengthNumber": "500",
"StrengthUnit": "U/1",
"Pharm_Classes": "Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091102",
"SamplePackage": "N",
"IndicationAndUsage": "DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 The treatment of cervical dystonia in adults (1.1), 2 The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2), 3 The treatment of spasticity in patients 2 years of age and older (1.3).",
"Description": "Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein. DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [see Contraindications (4) and Warnings and Precautions (5.3)]. The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. Due to specific details of the assay system, such as vehicle, dilution scheme and laboratory protocols, Units of biological activity of DYSPORT cannot be converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method."
},
{
"NDCCode": "15054-0500-9",
"PackageDescription": "1 VIAL in 1 CARTON (15054-0500-9) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "15054-0500-09",
"ProductNDC": "15054-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dysport",
"NonProprietaryName": "Botulinum Toxin Type A",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20091102",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125274",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "BOTULINUM TOXIN TYPE A",
"StrengthNumber": "500",
"StrengthUnit": "U/1",
"Pharm_Classes": "Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091102",
"SamplePackage": "Y",
"IndicationAndUsage": "DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 The treatment of cervical dystonia in adults (1.1), 2 The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2), 3 The treatment of spasticity in patients 2 years of age and older (1.3).",
"Description": "Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein. DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [see Contraindications (4) and Warnings and Precautions (5.3)]. The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. Due to specific details of the assay system, such as vehicle, dilution scheme and laboratory protocols, Units of biological activity of DYSPORT cannot be converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method."
},
{
"NDCCode": "15054-0530-6",
"PackageDescription": "1 VIAL in 1 CARTON (15054-0530-6) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "15054-0530-06",
"ProductNDC": "15054-0530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dysport",
"NonProprietaryName": "Botulinum Toxin Type A",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20091102",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125274",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "BOTULINUM TOXIN TYPE A",
"StrengthNumber": "300",
"StrengthUnit": "U/1",
"Pharm_Classes": "Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091102",
"SamplePackage": "N",
"IndicationAndUsage": "DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 The treatment of cervical dystonia in adults (1.1), 2 The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2), 3 The treatment of spasticity in patients 2 years of age and older (1.3).",
"Description": "Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein. DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [see Contraindications (4) and Warnings and Precautions (5.3)]. The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. Due to specific details of the assay system, such as vehicle, dilution scheme and laboratory protocols, Units of biological activity of DYSPORT cannot be converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method."
},
{
"NDCCode": "15054-1040-5",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (15054-1040-5) / 4 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "15054-1040-05",
"ProductNDC": "15054-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Increlex",
"NonProprietaryName": "Mecasermin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20060103",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021839",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "MECASERMIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/4mL",
"Status": "Active",
"LastUpdate": "2025-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060103",
"EndMarketingDatePackage": "20271231",
"SamplePackage": "N",
"IndicationAndUsage": "INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. (1). Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.",
"Description": "Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 Da. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesized in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1. INCRELEX (mecasermin) injection is a sterile, aqueous, clear and colorless solution intended for subcutaneous injection. Each multiple-dose vial of INCRELEX contains 40 mg of mecasermin in 4 mL solution, and each mL contains 10 mg mecasermin, 9 mg benzyl alcohol, 0.43 mg glacial acetic acid, 2 mg polysorbate 20, 3.51 mg sodium acetate, and 5.84 mg sodium chloride in Water for Injection, USP at a pH of approximately 5.4."
},
{
"NDCCode": "15054-1060-3",
"PackageDescription": "1 POUCH in 1 CARTON (15054-1060-3) > 1 SYRINGE in 1 POUCH > .2 mL in 1 SYRINGE",
"NDC11Code": "15054-1060-03",
"ProductNDC": "15054-1060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20071114",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "15054-1060-4",
"PackageDescription": "1 POUCH in 1 CARTON (15054-1060-4) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE",
"NDC11Code": "15054-1060-04",
"ProductNDC": "15054-1060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "SOMATULINE DEPOT is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).",
"Description": "SOMATULINE DEPOT (lanreotide) Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). SOMATULINE DEPOT is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The SOMATULINE DEPOT in the prefilled syringe is a white to pale yellow, semi-solid formulation."
},
{
"NDCCode": "15054-1090-3",
"PackageDescription": "1 POUCH in 1 CARTON (15054-1090-3) > 1 SYRINGE in 1 POUCH > .3 mL in 1 SYRINGE",
"NDC11Code": "15054-1090-03",
"ProductNDC": "15054-1090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "90",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20071114",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "15054-1090-4",
"PackageDescription": "1 POUCH in 1 CARTON (15054-1090-4) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE",
"NDC11Code": "15054-1090-04",
"ProductNDC": "15054-1090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "90",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "SOMATULINE DEPOT is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).",
"Description": "SOMATULINE DEPOT (lanreotide) Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). SOMATULINE DEPOT is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The SOMATULINE DEPOT in the prefilled syringe is a white to pale yellow, semi-solid formulation."
},
{
"NDCCode": "15054-1120-3",
"PackageDescription": "1 POUCH in 1 CARTON (15054-1120-3) > 1 SYRINGE in 1 POUCH > .5 mL in 1 SYRINGE",
"NDC11Code": "15054-1120-03",
"ProductNDC": "15054-1120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "120",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20071114",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "15054-1120-4",
"PackageDescription": "1 POUCH in 1 CARTON (15054-1120-4) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE",
"NDC11Code": "15054-1120-04",
"ProductNDC": "15054-1120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Somatuline Depot",
"NonProprietaryName": "Lanreotide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022074",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "LANREOTIDE ACETATE",
"StrengthNumber": "120",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "SOMATULINE DEPOT is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).",
"Description": "SOMATULINE DEPOT (lanreotide) Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). SOMATULINE DEPOT is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The SOMATULINE DEPOT in the prefilled syringe is a white to pale yellow, semi-solid formulation."
},
{
"NDCCode": "15054-3301-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE",
"NDC11Code": "15054-3301-01",
"ProductNDC": "15054-3301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bylvay",
"NonProprietaryName": "Odevixibat",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215498",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "ODEVIXIBAT",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for:. Progressive Familial Intrahepatic Cholestasis (PFIC): 1 the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.1).",
"Description": "The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ6,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure:. The molecular formula is C37H48N4O8S2 × 1.5 H2O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH. BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze."
},
{
"NDCCode": "15054-3302-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (15054-3302-1) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "15054-3302-01",
"ProductNDC": "15054-3302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bylvay",
"NonProprietaryName": "Odevixibat",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215498",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "ODEVIXIBAT",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for:. Progressive Familial Intrahepatic Cholestasis (PFIC): 1 the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.1).",
"Description": "The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ6,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure:. The molecular formula is C37H48N4O8S2 × 1.5 H2O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH. BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze."
},
{
"NDCCode": "15054-3303-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (15054-3303-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE",
"NDC11Code": "15054-3303-01",
"ProductNDC": "15054-3303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bylvay",
"NonProprietaryName": "Odevixibat",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215498",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "ODEVIXIBAT",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for:. Progressive Familial Intrahepatic Cholestasis (PFIC): 1 the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.1).",
"Description": "The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ6,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure:. The molecular formula is C37H48N4O8S2 × 1.5 H2O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH. BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze."
},
{
"NDCCode": "15054-3304-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (15054-3304-1) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "15054-3304-01",
"ProductNDC": "15054-3304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bylvay",
"NonProprietaryName": "Odevixibat",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215498",
"LabelerName": "Ipsen Biopharmaceuticals, Inc.",
"SubstanceName": "ODEVIXIBAT",
"StrengthNumber": "1200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for:. Progressive Familial Intrahepatic Cholestasis (PFIC): 1 the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.1).",
"Description": "The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ6,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure:. The molecular formula is C37H48N4O8S2 × 1.5 H2O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH. BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze."
},
{
"NDCCode": "0054-0010-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00054-0010-20",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0054-0010-21",
"PackageDescription": "60 TABLET in 1 BOTTLE (0054-0010-21) ",
"NDC11Code": "00054-0010-21",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0054-0010-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0010-25) ",
"NDC11Code": "00054-0010-25",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0074-3575-01",
"PackageDescription": "1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01) ",
"NDC11Code": "00074-3575-01",
"ProductNDC": "0074-3575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20230414",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230414",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>15054-0010-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (15054-0010-1) / 14 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15054-0010-01</NDC11Code>
<ProductNDC>15054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sohonos</ProprietaryName>
<NonProprietaryName>Palovarotene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215559</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALOVAROTENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).</IndicationAndUsage>
<Description>Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac.</Description>
</NDC>
<NDC>
<NDCCode>15054-0015-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (15054-0015-1) / 14 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15054-0015-01</NDC11Code>
<ProductNDC>15054-0015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sohonos</ProprietaryName>
<NonProprietaryName>Palovarotene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215559</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALOVAROTENE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).</IndicationAndUsage>
<Description>Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac.</Description>
</NDC>
<NDC>
<NDCCode>15054-0025-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (15054-0025-1) / 14 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15054-0025-01</NDC11Code>
<ProductNDC>15054-0025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sohonos</ProprietaryName>
<NonProprietaryName>Palovarotene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230816</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215559</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALOVAROTENE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230816</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).</IndicationAndUsage>
<Description>Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac.</Description>
</NDC>
<NDC>
<NDCCode>15054-0043-1</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>15054-0043-01</NDC11Code>
<ProductNDC>15054-0043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Onivyde</ProprietaryName>
<NonProprietaryName>Irinotecan Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207793</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.</IndicationAndUsage>
<Description>ONIVYDE is formulated with irinotecan hydrochloride trihydrate, a topoisomerase inhibitor, into a liposomal dispersion for intravenous use. The chemical name of irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate. The empirical formula is C33H38N4O6∙HCl∙3H2O and the molecular weight is 677.19 g/mole. The molecular structure is. ONIVYDE is a sterile, white to slightly yellow opaque isotonic liposomal dispersion. Each 10 mL single-dose vial contains 43 mg irinotecan free base at a concentration of 4.3 mg/mL. The liposome is a unilamellar lipid bilayer vesicle, approximately 110 nm in diameter, which encapsulates an aqueous space containing irinotecan in a gelated or precipitated state as the sucrose octasulfate salt. The vesicle is composed of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) 6.81 mg/mL, cholesterol 2.22 mg/mL, and methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidyl ethanolamine (MPEG-2000-DSPE) 0.12 mg/mL. Each mL also contains 2-[4-(2-hydroxyethyl) piperazin-1-yl]ethanesulfonic acid (HEPES) as a buffer 4.05 mg/mL and sodium chloride as an isotonicity reagent 8.42 mg/mL.</Description>
</NDC>
<NDC>
<NDCCode>15054-0050-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (15054-0050-1) / 14 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15054-0050-01</NDC11Code>
<ProductNDC>15054-0050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sohonos</ProprietaryName>
<NonProprietaryName>Palovarotene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215559</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALOVAROTENE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).</IndicationAndUsage>
<Description>Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac.</Description>
</NDC>
<NDC>
<NDCCode>15054-0060-1</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-0060-1) > 1 SYRINGE in 1 POUCH > .2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-0060-01</NDC11Code>
<ProductNDC>15054-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15054-0080-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>15054-0080-01</NDC11Code>
<ProductNDC>15054-0080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iqirvo</ProprietaryName>
<NonProprietaryName>Elafibranor</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218860</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELAFIBRANOR</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inducers [MoA], Peroxisome Proliferator-activated Receptor Agonist [EPC], Peroxisome Proliferator-activated Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP) [see Clinical Studies (14)]. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists. Elafibranor is practically insoluble in aqueous media at pH in the range 1.2 to 6.8. It is very slightly soluble at pH 7.5. It is soluble in dichloromethane, freely soluble in DMSO and sparingly soluble in 2-propanol and ethanol. Its chemical formula is C22H24O4S, the molecular weight is 384.49 g/mol, the chemical name is 2-(2,6-Dimethyl-4-{3-[4-(methylsulfanyl)phenyl]-3-oxoprop-1-en-1-yl}phenoxy)-2-methylpropanoic acid and it has the following structural formula. IQIRVO (elafibranor) tablets are supplied as 80 mg film-coated tablets for oral administration. Each tablet contains 80 mg elafibranor and the following inactive ingredients: colloidal silica dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone. The film coating consists of: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>15054-0090-1</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-0090-1) > 1 SYRINGE in 1 POUCH > .3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-0090-01</NDC11Code>
<ProductNDC>15054-0090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15054-0100-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (15054-0100-1) / 14 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15054-0100-01</NDC11Code>
<ProductNDC>15054-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sohonos</ProprietaryName>
<NonProprietaryName>Palovarotene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215559</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALOVAROTENE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).</IndicationAndUsage>
<Description>Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac.</Description>
</NDC>
<NDC>
<NDCCode>15054-0120-1</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-0120-1) > 1 SYRINGE in 1 POUCH > .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-0120-01</NDC11Code>
<ProductNDC>15054-0120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15054-0211-5</NDCCode>
<PackageDescription>5 CARTRIDGE in 1 CARTON (15054-0211-5) > 3 mL in 1 CARTRIDGE (15054-0211-1)</PackageDescription>
<NDC11Code>15054-0211-05</NDC11Code>
<ProductNDC>15054-0211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apokyn</ProprietaryName>
<NonProprietaryName>Apomorphine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040702</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021264</ApplicationNumber>
<LabelerName>Tercica, Inc.</LabelerName>
<SubstanceName>APOMORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15054-0500-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (15054-0500-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>15054-0500-01</NDC11Code>
<ProductNDC>15054-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dysport</ProprietaryName>
<NonProprietaryName>Botulinum Toxin Type A</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20091102</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125274</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>BOTULINUM TOXIN TYPE A</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>U/1</StrengthUnit>
<Pharm_Classes>Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 The treatment of cervical dystonia in adults (1.1), 2 The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2), 3 The treatment of spasticity in patients 2 years of age and older (1.3).</IndicationAndUsage>
<Description>Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein. DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [see Contraindications (4) and Warnings and Precautions (5.3)]. The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. Due to specific details of the assay system, such as vehicle, dilution scheme and laboratory protocols, Units of biological activity of DYSPORT cannot be converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method.</Description>
</NDC>
<NDC>
<NDCCode>15054-0500-2</NDCCode>
<PackageDescription>2 VIAL in 1 CARTON (15054-0500-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>15054-0500-02</NDC11Code>
<ProductNDC>15054-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dysport</ProprietaryName>
<NonProprietaryName>Botulinum Toxin Type A</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20091102</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125274</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>BOTULINUM TOXIN TYPE A</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>U/1</StrengthUnit>
<Pharm_Classes>Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 The treatment of cervical dystonia in adults (1.1), 2 The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2), 3 The treatment of spasticity in patients 2 years of age and older (1.3).</IndicationAndUsage>
<Description>Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein. DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [see Contraindications (4) and Warnings and Precautions (5.3)]. The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. Due to specific details of the assay system, such as vehicle, dilution scheme and laboratory protocols, Units of biological activity of DYSPORT cannot be converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method.</Description>
</NDC>
<NDC>
<NDCCode>15054-0500-9</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (15054-0500-9) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>15054-0500-09</NDC11Code>
<ProductNDC>15054-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dysport</ProprietaryName>
<NonProprietaryName>Botulinum Toxin Type A</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20091102</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125274</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>BOTULINUM TOXIN TYPE A</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>U/1</StrengthUnit>
<Pharm_Classes>Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091102</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 The treatment of cervical dystonia in adults (1.1), 2 The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2), 3 The treatment of spasticity in patients 2 years of age and older (1.3).</IndicationAndUsage>
<Description>Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein. DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [see Contraindications (4) and Warnings and Precautions (5.3)]. The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. Due to specific details of the assay system, such as vehicle, dilution scheme and laboratory protocols, Units of biological activity of DYSPORT cannot be converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method.</Description>
</NDC>
<NDC>
<NDCCode>15054-0530-6</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (15054-0530-6) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>15054-0530-06</NDC11Code>
<ProductNDC>15054-0530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dysport</ProprietaryName>
<NonProprietaryName>Botulinum Toxin Type A</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20091102</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125274</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>BOTULINUM TOXIN TYPE A</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/1</StrengthUnit>
<Pharm_Classes>Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 The treatment of cervical dystonia in adults (1.1), 2 The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2), 3 The treatment of spasticity in patients 2 years of age and older (1.3).</IndicationAndUsage>
<Description>Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein. DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [see Contraindications (4) and Warnings and Precautions (5.3)]. The primary release procedure for DYSPORT uses a cell-based potency assay to determine the potency relative to a reference standard. The assay and reference material are specific to DYSPORT. One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. Due to specific details of the assay system, such as vehicle, dilution scheme and laboratory protocols, Units of biological activity of DYSPORT cannot be converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method.</Description>
</NDC>
<NDC>
<NDCCode>15054-1040-5</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (15054-1040-5) / 4 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>15054-1040-05</NDC11Code>
<ProductNDC>15054-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Increlex</ProprietaryName>
<NonProprietaryName>Mecasermin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060103</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021839</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>MECASERMIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060103</StartMarketingDatePackage>
<EndMarketingDatePackage>20271231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. (1). Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.</IndicationAndUsage>
<Description>Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 Da. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesized in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1. INCRELEX (mecasermin) injection is a sterile, aqueous, clear and colorless solution intended for subcutaneous injection. Each multiple-dose vial of INCRELEX contains 40 mg of mecasermin in 4 mL solution, and each mL contains 10 mg mecasermin, 9 mg benzyl alcohol, 0.43 mg glacial acetic acid, 2 mg polysorbate 20, 3.51 mg sodium acetate, and 5.84 mg sodium chloride in Water for Injection, USP at a pH of approximately 5.4.</Description>
</NDC>
<NDC>
<NDCCode>15054-1060-3</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-1060-3) > 1 SYRINGE in 1 POUCH > .2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-1060-03</NDC11Code>
<ProductNDC>15054-1060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071114</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15054-1060-4</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-1060-4) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-1060-04</NDC11Code>
<ProductNDC>15054-1060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOMATULINE DEPOT is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).</IndicationAndUsage>
<Description>SOMATULINE DEPOT (lanreotide) Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). SOMATULINE DEPOT is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The SOMATULINE DEPOT in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
</NDC>
<NDC>
<NDCCode>15054-1090-3</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-1090-3) > 1 SYRINGE in 1 POUCH > .3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-1090-03</NDC11Code>
<ProductNDC>15054-1090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071114</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15054-1090-4</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-1090-4) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-1090-04</NDC11Code>
<ProductNDC>15054-1090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOMATULINE DEPOT is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).</IndicationAndUsage>
<Description>SOMATULINE DEPOT (lanreotide) Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). SOMATULINE DEPOT is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The SOMATULINE DEPOT in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
</NDC>
<NDC>
<NDCCode>15054-1120-3</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-1120-3) > 1 SYRINGE in 1 POUCH > .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-1120-03</NDC11Code>
<ProductNDC>15054-1120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071114</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15054-1120-4</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (15054-1120-4) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>15054-1120-04</NDC11Code>
<ProductNDC>15054-1120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Somatuline Depot</ProprietaryName>
<NonProprietaryName>Lanreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022074</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANREOTIDE ACETATE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOMATULINE DEPOT is a somatostatin analog indicated for: 1 the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1), 2 the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2), 3 the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. (1.3).</IndicationAndUsage>
<Description>SOMATULINE DEPOT (lanreotide) Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). SOMATULINE DEPOT is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is. The SOMATULINE DEPOT in the prefilled syringe is a white to pale yellow, semi-solid formulation.</Description>
</NDC>
<NDC>
<NDCCode>15054-3301-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE</PackageDescription>
<NDC11Code>15054-3301-01</NDC11Code>
<ProductNDC>15054-3301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bylvay</ProprietaryName>
<NonProprietaryName>Odevixibat</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240110</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215498</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>ODEVIXIBAT</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for:. Progressive Familial Intrahepatic Cholestasis (PFIC): 1 the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.1).</IndicationAndUsage>
<Description>The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ6,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure:. The molecular formula is C37H48N4O8S2 × 1.5 H2O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH. BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>15054-3302-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (15054-3302-1) / 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>15054-3302-01</NDC11Code>
<ProductNDC>15054-3302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bylvay</ProprietaryName>
<NonProprietaryName>Odevixibat</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240110</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215498</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>ODEVIXIBAT</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for:. Progressive Familial Intrahepatic Cholestasis (PFIC): 1 the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.1).</IndicationAndUsage>
<Description>The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ6,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure:. The molecular formula is C37H48N4O8S2 × 1.5 H2O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH. BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>15054-3303-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (15054-3303-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE</PackageDescription>
<NDC11Code>15054-3303-01</NDC11Code>
<ProductNDC>15054-3303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bylvay</ProprietaryName>
<NonProprietaryName>Odevixibat</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240110</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215498</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>ODEVIXIBAT</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for:. Progressive Familial Intrahepatic Cholestasis (PFIC): 1 the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.1).</IndicationAndUsage>
<Description>The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ6,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure:. The molecular formula is C37H48N4O8S2 × 1.5 H2O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH. BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>15054-3304-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (15054-3304-1) / 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>15054-3304-01</NDC11Code>
<ProductNDC>15054-3304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bylvay</ProprietaryName>
<NonProprietaryName>Odevixibat</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240110</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215498</ApplicationNumber>
<LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
<SubstanceName>ODEVIXIBAT</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for:. Progressive Familial Intrahepatic Cholestasis (PFIC): 1 the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.1).</IndicationAndUsage>
<Description>The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ6,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure:. The molecular formula is C37H48N4O8S2 × 1.5 H2O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH. BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0054-0010-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00054-0010-20</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0010-21</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0054-0010-21) </PackageDescription>
<NDC11Code>00054-0010-21</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0010-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0010-25) </PackageDescription>
<NDC11Code>00054-0010-25</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0074-3575-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01) </PackageDescription>
<NDC11Code>00074-3575-01</NDC11Code>
<ProductNDC>0074-3575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230414</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
</NDCList>