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USFDA APPLICATION NUMBER - 22350 / DOSAGE - TABLET;ORAL - EQ 5MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| saxagliptin hydrochloride(UNII: Z8J84YIX6L) (saxagliptin anhydrous - UNII:8I7IO46IVQ) | saxagliptin anhydrous | 5mg |
Inactive Ingredients
| Ingredient Name | Amneal Pharmaceuticals LLC | Glenmark Pharmaceuticals Inc., USA | E.R. Squibb & Sons, L.L.C. | Cardinal Health |
|---|---|---|---|---|
| AMMONIA(5138Q19F1X) | ||||
| BUTYL ALCOHOL(8PJ61P6TS3) | ||||
| cellulose, microcrystalline(OP1R32D61U) | ||||
| croscarmellose sodium(M28OL1HH48) | ||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||
| FERRIC OXIDE RED(1K09F3G675) | ||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||
| HYDROCHLORIC ACID(QTT17582CB) | ||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
| HYPROMELLOSES(3NXW29V3WO) | ||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||
| lactose monohydrate(EWQ57Q8I5X) | ||||
| magnesium stearate(70097M6I30) | ||||
| MANNITOL(3OWL53L36A) | ||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||
| POVIDONE(FZ989GH94E) | ||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||
| SHELLAC(46N107B71O) | ||||
| TALC(7SEV7J4R1U) | ||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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