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USFDA APPLICATION NUMBER - 21588 / DOSAGE - TABLET;ORAL - EQ 400MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| IMATINIB MESYLATE(UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI) | IMATINIB | 100mg |
Inactive Ingredients
| Ingredient Name | Avera McKennan Hospital | BluePoint Laboratories | NorthStar RxLLC | Sun Pharmaceutical Industries, Inc. | Golden State Medical Supply, Inc. | Teva Pharmaceuticals USA, Inc. | Breckenridge Pharmaceutical, Inc. | Bryant Ranch Prepack | AvPAK | AvKARE, Inc. | Armas Pharmaceuticals Inc. | Ascend Laboratories, LLC | CELLTRION USA, INC. | Lupin Pharmaceuticals, Inc. | Wockhardt USA LLC. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||
| COPOVIDONE K25-31(D9C330MD8B) | |||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||||||
| CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9) | |||||||||||||||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | |||||||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |||||||||||||||
| CROSPOVIDONE(68401960MK) | |||||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||||
| HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F) | |||||||||||||||
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | |||||||||||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | |||||||||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |||||||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||
| MANNITOL(3OWL53L36A) | |||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |||||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||||||||||
| POVIDONE(FZ989GH94E) | |||||||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | |||||||||||||||
| TALC(7SEV7J4R1U) | |||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
