Details for New Drug Application (NDA): 217482
NDA 217482 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon Research, Sciegen Pharms, Sun Pharm Inds, Rising, Sun Pharm, Actavis Elizabeth, Ani Pharms, Apotex Inc, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pharmobedient, 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 is one drug master file entry for this compound. Thirty-eight 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 is one drug master file entry for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 217482
| Tradename: | CARBIDOPA AND LEVODOPA |
| Applicant: | Rubicon Research |
| Ingredient: | carbidopa; levodopa |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217482
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 217482 | ANDA | Advagen Pharma Ltd | 72888-155 | 72888-155-00 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-00) |
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 217482 | ANDA | Advagen Pharma Ltd | 72888-155 | 72888-155-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Jun 4, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG;200MG | ||||
| Approval Date: | Jun 4, 2024 | TE: | AB | RLD: | No | ||||
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