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USFDA APPLICATION NUMBER - 217729 / DOSAGE - CAPSULE;ORAL - EQ 50MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| BOSUTINIB MONOHYDRATE(UNII: 844ZJE6I55) (BOSUTINIB - UNII:5018V4AEZ0) | BOSUTINIB | 100mg | 50mg | 400mg | 500mg | 100mg |
Inactive Ingredients
| Ingredient Name | Pfizer Laboratories Div Pfizer Inc |
|---|---|
| AMMONIA(5138Q19F1X) | |
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |
| FERRIC OXIDE RED(1K09F3G675) | |
| FERRIC OXIDE YELLOW(EX438O2MRT) | |
| FERROSOFERRIC OXIDE(XM0M87F357) | |
| GELATIN, UNSPECIFIED(2G86QN327L) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| MANNITOL(3OWL53L36A) | |
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |
| POLOXAMER 188(LQA7B6G8JG) | |
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | |
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |
| POVIDONE K25(K0KQV10C35) | |
| PROPYLENE GLYCOL(6DC9Q167V3) | |
| SHELLAC(46N107B71O) | |
| TALC(7SEV7J4R1U) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |
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