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USFDA APPLICATION NUMBER - 21485 / DOSAGE - TABLET;ORAL - 25MG;200MG;100MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| CARBIDOPA(UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) | CARBIDOPA ANHYDROUS | 50mg | 37.5mg | 31.25mg | 25mg | 18.75mg | 12.5mg |
| ENTACAPONE(UNII: 4975G9NM6T) (ENTACAPONE - UNII:4975G9NM6T) | ENTACAPONE | 200mg | 200mg | 200mg | 200mg | 200mg | 200mg |
| LEVODOPA(UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) | LEVODOPA | 200mg | 150mg | 125mg | 100mg | 75mg | 50mg |
Inactive Ingredients
| Ingredient Name | Sun Pharma Global FZE | Mylan Pharmaceuticals Inc. | Novartis Pharmaceuticals Corporation | Wockhardt Limited |
|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||||
| FERRIC OXIDE RED(1K09F3G675) | ||||
| ferric oxide yellow(EX438O2MRT) | ||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||
| GLYCERIN(PDC6A3C0OX) | ||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
| HYPROMELLOSES(3NXW29V3WO) | ||||
| LECITHIN, SOYBEAN(1DI56QDM62) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| MANNITOL(3OWL53L36A) | ||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||
| POLYSORBATE 80(6OZP39ZG8H) | ||||
| POLYVINYL ALCOHOL(532B59J990) | ||||
| POVIDONE K30(U725QWY32X) | ||||
| POVIDONE(FZ989GH94E) | ||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||
| STARCH, CORN(O8232NY3SJ) | ||||
| SUCROSE(C151H8M554) | ||||
| TALC(7SEV7J4R1U) | ||||
| titanium dioxide(15FIX9V2JP) |
