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USFDA APPLICATION NUMBER - 21518 / DOSAGE - TABLET;ORAL - 5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| SOLIFENACIN SUCCINATE(UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U) | SOLIFENACIN SUCCINATE | 5mg |
Inactive Ingredients
| Ingredient Name | Sunshine Lake Pharma Co., Ltd. | Teva Pharmaceuticals USA, Inc. | Cipla USA Inc. | Breckenridge Pharmaceutical, Inc. | American Health Packaging | Glenmark Pharmaceuticals Inc., USA | CELLTRION USA, INC. | Golden State Medical Supply Inc. | Graviti Pharmaceuticals Private Limited | Unichem Pharmaceuticals (USA), Inc. | Proficient Rx LP |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||||||
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | |||||||||||
| BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | |||||||||||
| CROSPOVIDONE(2S7830E561) | |||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||
| HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | |||||||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | |||||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||||
| Isopropyl Alcohol(ND2M416302) | |||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||
| POLYETHYLENE GLYCOL 1000(U076Q6Q621) | |||||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||
| POLYVINYL ALCOHOL (100000 MW)(949E52Z6MY) | |||||||||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||||||||||
| POVIDONE(FZ989GH94E) | |||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||
| TALC(7SEV7J4R1U) | |||||||||||
| TARTARIC ACID(W4888I119H) | |||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||
| TRIACETIN(XHX3C3X673) | |||||||||||
| WATER(059QF0KO0R) |
