USFDA APPLICATION NUMBER - 21615 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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) | GALANTAMINE | 24mg | 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) |
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