Drug Product Composition: Desvenlafaxine Fumarate

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3 API Suppliers, 2 USDMF, 1 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 100MG 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