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USFDA APPLICATION NUMBER - 21169 / DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 | 12mg |
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) |
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