USFDA APPLICATION NUMBER - 21455 / DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
---|---|---|
IBANDRONATE SODIUM(UNII: J12U072QL0) (IBANDRONIC ACID - UNII:UMD7G2653W) | IBANDRONIC ACID | 150mg |
Inactive Ingredients
Ingredient Name | Genentech, Inc. |
---|---|
CROSPOVIDONE (120 .MU.M)(68401960MK) | |
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |
POLYETHYLENE GLYCOL 6000(30IQX730WE) | |
POVIDONE K25(K0KQV10C35) | |
SILICON DIOXIDE(ETJ7Z6XBU4) | |
STEARIC ACID(4ELV7Z65AP) | |
TALC(7SEV7J4R1U) | |
TITANIUM DIOXIDE(15FIX9V2JP) |
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