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USFDA APPLICATION NUMBER - 202379 / DOSAGE - TABLET;ORAL - 250MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Abiraterone acetate(UNII: EM5OCB9YJ6) (Abiraterone - UNII:G819A456D0) | Abiraterone acetate | 500mg | 250mg |
Inactive Ingredients
| Ingredient Name | Amneal Pharmaceuticals NY LLC | AvKARE | CELLTRION USA, INC. | Hikma Pharmaceuticals USA Inc. | Rising Pharmaceuticals, Inc. | Glenmark Pharmaceuticals Inc., USA | Golden State Medical Supply, Inc. | Janssen Biotech, Inc. | Mylan Pharmaceuticals Inc. | Apotex Corp. | Major Pharmaceuticals |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | |||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |||||||||||
| ferric oxide red(1K09F3G675) | |||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||
| Hypromellose 2910 (15 MPA.S)(36SFW2JZ0W) | |||||||||||
| HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | |||||||||||
| HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N) | |||||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||
| magnesium stearate(70097M6I30) | |||||||||||
| MICROCRYSTALLINE CELLULOSE 101(7T9FYH5QMK) | |||||||||||
| MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y) | |||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||
| POLYDEXTROSE(VH2XOU12IE) | |||||||||||
| polyethylene glycol 3350(G2M7P15E5P) | |||||||||||
| POLYETHYLENE GLYCOL 4000(4R4HFI6D95) | |||||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||
| polyvinyl alcohol, unspecified(532B59J990) | |||||||||||
| POVIDONE K30(U725QWY32X) | |||||||||||
| POVIDONE(FZ989GH94E) | |||||||||||
| povidone, unspecified(FZ989GH94E) | |||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||
| TALC(7SEV7J4R1U) | |||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||
| TRIACETIN(XHX3C3X673) | |||||||||||
| Water(059QF0KO0R) |
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