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USFDA APPLICATION NUMBER - 200603 / DOSAGE - TABLET;ORAL - 120MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| LURASIDONE HYDROCHLORIDE(UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) | LURASIDONE HYDROCHLORIDE | 80mg | 40mg |
Inactive Ingredients
| Ingredient Name | Ascend Laboratories, LLC | Major Pharmaceuticals | Avera McKennan Hospital | Bushu Pharmaceutical, LTD. | REMEDYREPACK INC. | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | Lupin Pharmaceuticals, Inc. | Torrent Pharmaceuticals Limited |
|---|---|---|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |||||||||
| CARNAUBA WAX(R12CBM0EIZ) | |||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||
| 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) | |||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |||||||||
| POLYETHYLENE GLYCOL 6000(30IQX730WE) | |||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |||||||||
| POVIDONE K30(U725QWY32X) | |||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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