Setid C283f677 7c33 4d8a 8f4c 92a713eaa5ad Applno 205583 Form Tablet Extended Release Oral Dosage Eq 50mg Base - Drug Product Composition: Desvenlafaxine Fumarate

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5 API Suppliers, 2 USDMF, 3 Listed Suppliers

4 FDF Dossiers, 4 FDA Orange Book

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

1 Others

Xls

USFDA APPLICATION NUMBER - 205583 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DESVENLAFAXINE FUMARATE MONOHYDRATE(UNII: R5JHD7L72A) (DESVENLAFAXINE - UNII:NG99554ANW)	DESVENLAFAXINE	100mg \| 50mg

Inactive Ingredients

Ingredient Name	Sun Pharma Global FZE
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Desvenlafaxine Fumarate