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USFDA APPLICATION NUMBER - 20835 / DOSAGE - TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| RISEDRONATE SODIUM(UNII: OFG5EXG60L) (risedronic acid - UNII:KM2Z91756Z) | RISEDRONATE SODIUM | 5mg | 30mg | 35mg | 75mg | 150mg |
Inactive Ingredients
| Ingredient Name | Warner Chilcott Pharmaceuticals Inc. | Actavis Pharma, Inc. | Allergan, Inc. |
|---|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | |||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||
| CROSPOVIDONE(2S7830E561) | |||
| CROSPOVIDONE(68401960MK) | |||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||
| FERRIC OXIDE RED(1K09F3G675) | |||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | |||
| HYDROXYPROPYL CELLULOSE(RFW2ET671P) | |||
| HYPROMELLOSE(3NXW29V3WO) | |||
| HYPROMELLOSES(3NXW29V3WO) | |||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||
| MAGNESIUM STEARATE(70097M6I30) | |||
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | |||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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