(4R,12aS)-N-[(2,4-Difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide | 205551 | TABLET;ORAL | EQ 600MG BASE;EQ 50MG BASE;300MG

(4R,12aS)-N-[(2,4-Difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1 ,3]oxazine-9-carboxamide

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ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 27 USDMF, 12 EU WC, 2 KDMF, 12 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

154 Drugs in Development

154 Drugs in Development

INTERMEDIATES

40 Intermediate Suppliers

40 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

134 FDF Dossiers, 30 FDA Orange Book, 27 Europe, 5 Canada, 4 Australia, 63 South Africa, 5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 15 SPI Pharma, 3 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 1 Kirsch Pharma, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 20 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 2 Ideal Cures, 2 Ingredion Pharma Solutions, 14 Kerry, 2 Keval Exports, 12 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 13 Roquette, 2 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

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PATENTS & EXCLUSIVITIES

36 US Patents, 5 US Exclusivities, 17 Health Canada Patents

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USFDA APPLICATION NUMBER - 205551 / DOSAGE - TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ABACAVIR SULFATE(UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)	ABACAVIR	600mg
DOLUTEGRAVIR SODIUM(UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1)	DOLUTEGRAVIR	50mg
LAMIVUDINE(UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)	LAMIVUDINE	300mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Glaxo Operations UK Ltd
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 815f0409 E465 4791 Ab3d A97e6f3cead4 Applno 205551 Form Tablet Oral Dosage Eq 600mg Base Eq 50mg Base 300mg - Drug Product Composition: (4R,12aS)-N-[(2,4-Difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide