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Drug Product Composition: Galanthamine

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$ API Ref.Price (USD/KG) : 5,234Xls

USFDA APPLICATION NUMBER - 21169 / DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
galantamine hydrobromide(UNII: MJ4PTD2VVW)
(galantamine - UNII:0D3Q044KCA)
galantamine12mg

Inactive Ingredients

Ingredient Name
Avera McKennan Hospital
Janssen Pharmaceuticals, Inc.
aluminum oxide(LMI26O6933)
cellulose, microcrystalline(OP1R32D61U) 
CROSPOVIDONE (120 .MU.M)(68401960MK) 
crospovidone (15 mpa.s at 5%)(68401960MK) 
crospovidone(68401960MK) 
D&C Yellow No. 10(35SW5USQ3G)
diethyl phthalate(UF064M00AF) 
ethylcellulose, unspecified(7Z8S9VYZ4B) 
ferric oxide red(1K09F3G675)
ferric oxide yellow(EX438O2MRT)
gelatin, unspecified(2G86QN327L) 
hypromellose, unspecified(3NXW29V3WO)
hypromelloses(3NXW29V3WO) 
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
polyethylene glycol, unspecified(3WJQ0SDW1A) 
silicon dioxide(ETJ7Z6XBU4)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)