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Setid 3bea9961 4d8a 4cf3 8b63 49af2b1fbb5b Applno 21615 Form Capsule Extended Release Oral Dosage Eq 16mg Base - Drug Product Composition: Galantamine Hydrobromide

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$ API Ref.Price (USD/KG) : 4,406Xls

USFDA APPLICATION NUMBER - 21615 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
GALANTAMINE24mg | 16mg | 8mg

Inactive Ingredients

Ingredient Name
Janssen Pharmaceuticals, Inc.
Patriot Pharmaceuticals, LLC
aluminum oxide(LMI26O6933) 
CROSPOVIDONE (120 .MU.M)(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)
lactose monohydrate(EWQ57Q8I5X) 
magnesium stearate(70097M6I30) 
microcrystalline cellulose(OP1R32D61U) 
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
silicon dioxide(ETJ7Z6XBU4) 
talc(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)