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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- CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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