(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 | 204790 | TABLET;ORAL | EQ 50MG BASE

(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

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40 Intermediate Suppliers

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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

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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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USFDA APPLICATION NUMBER - 204790 / DOSAGE - TABLET;ORAL - EQ 50MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOLUTEGRAVIR SODIUM(UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1)	DOLUTEGRAVIR	50mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	REMEDYREPACK INC.
FERRIC OXIDE YELLOW(EX438O2MRT)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 30b06939 De33 48be 9dd3 Dc9741c96724 Applno 204790 Form Tablet Oral Dosage Eq 50mg Base - 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