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USFDA APPLICATION NUMBER - 20560 / DOSAGE - TABLET;ORAL - EQ 70MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ALENDRONATE SODIUM(UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P) | ALENDRONIC ACID | 70mg |
Inactive Ingredients
| Ingredient Name | Merck Sharp & Dohme Corp. | A-S Medication Solutions | Actavis Pharma, Inc. | Amneal Pharmaceuticals of New York LLC | Apotex Corp. | Avera McKennan Hospital | Cipla USA Inc. | DIRECT RX | Direct_Rx | EXELAN PHARMACEUTICALS INC. | Jubilant Cadista Pharmaceuticals Inc. | Marlex Pharmaceuticals Inc | Mylan Institutional Inc. | NuCare Pharmaceuticals,Inc. | RedPharm Drug, Inc | REMEDYREPACK INC. | Sun Pharma Global FZE | Sun Pharma Global Inc. | Unit Dose Services | Bryant Ranch Prepack | Golden State Medical Supply, Inc. | Preferred Pharmaceuticals Inc. | Proficient Rx LP | Teva Pharmaceuticals USA, Inc. | Virtus Pharmaceuticals | Mylan Pharmaceuticals Inc. | Aurobindo Pharma Limited | NorthStar Rx LLC | Preferred Pharmaceuticals, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||||||||||||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||||||||||||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |||||||||||||||||||||||||||||
| Lactose Monohydrate(EWQ57Q8I5X) | |||||||||||||||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||||||||||||||||
| MANNITOL(3OWL53L36A) | |||||||||||||||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||||||||||||||||
| POVIDONE K30(U725QWY32X) | |||||||||||||||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||||||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||||||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||||||||||||||||||||
| STARCH, CORN(O8232NY3SJ) |
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