
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- 21455 / DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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) |