USFDA APPLICATION NUMBER - 20835 / DOSAGE - TABLET;ORAL - 30MG
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. | Mylan Pharmaceuticals Inc. |
---|---|---|---|---|
ALUMINUM OXIDE(LMI26O6933) | ||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||||
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) | ||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
HYPROMELLOSES(3NXW29V3WO) | ||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||
MAGNESIUM STEARATE(70097M6I30) | ||||
MANNITOL(3OWL53L36A) | ||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
POLYDEXTROSE(VH2XOU12IE) | ||||
POLYETHYLENE GLYCOL(3WJQ0SDW1A) | ||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||
SILICON DIOXIDE(ETJ7Z6XBU4) | ||||
TITANIUM DIOXIDE(15FIX9V2JP) | ||||
TRIACETIN(XHX3C3X673) |
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