Details for New Drug Application (NDA): 218939
✉ Email this page to a colleague
NDA 218939 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon, Sciegen Pharms Inc, Sun Pharm Inds, Rising, Sun Pharm, Actavis Elizabeth, Ani Pharms, Apotex Inc, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Norvium Bioscience, SCS, Watson Labs, and Zydus Pharms, and is included in twenty-nine NDAs. It is available from thirty-three suppliers. Additional details are available on the CARBIDOPA AND LEVODOPA profile page.
The generic ingredient in CARBIDOPA AND LEVODOPA is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
The generic ingredient in CARBIDOPA AND LEVODOPA is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 218939
| Tradename: | CARBIDOPA AND LEVODOPA |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | carbidopa; levodopa |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218939
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 218939 | ANDA | Ascent Pharmaceuticals, Inc. | 43602-671 | 43602-671-10 | 1000 TABLET in 1 BOTTLE (43602-671-10) |
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 218939 | ANDA | Ascent Pharmaceuticals, Inc. | 43602-671 | 43602-671-30 | 30 TABLET in 1 BOTTLE (43602-671-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;100MG | ||||
| Approval Date: | Jan 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Jan 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;250MG | ||||
| Approval Date: | Jan 14, 2025 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
