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USFDA APPLICATION NUMBER - 21485 / DOSAGE - TABLET;ORAL - 50MG;200MG;200MG
| 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 | Mylan Pharmaceuticals Inc. | Novartis Pharmaceuticals Corporation | Wockhardt Limited |
|---|---|---|---|
| croscarmellose sodium(M28OL1HH48) | |||
| FERRIC OXIDE RED(1K09F3G675) | |||
| ferric oxide yellow(EX438O2MRT) | |||
| glycerin(PDC6A3C0OX) | |||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||
| HYPROMELLOSES(3NXW29V3WO) | |||
| MAGNESIUM STEARATE(70097M6I30) | |||
| mannitol(3OWL53L36A) | |||
| POLYSORBATE 80(6OZP39ZG8H) | |||
| POVIDONE(FZ989GH94E) | |||
| povidone, unspecified(FZ989GH94E) | |||
| STARCH, CORN(O8232NY3SJ) | |||
| sucrose(C151H8M554) | |||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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