Details for New Drug Application (NDA): 202323
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NDA 202323 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon Research, 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, Pharmobedient, SCS, Watson Labs, and Zydus Pharms, and is included in twenty-nine NDAs. It is available from thirty-one 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-six 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-six suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 202323
| Tradename: | CARBIDOPA AND LEVODOPA |
| Applicant: | Accord Hlthcare |
| Ingredient: | carbidopa; levodopa |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202323
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 202323 | ANDA | Accord Healthcare, Inc. | 16729-078 | 16729-078-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-01) |
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 202323 | ANDA | Accord Healthcare, Inc. | 16729-078 | 16729-078-17 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-17) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Feb 8, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG;200MG | ||||
| Approval Date: | Feb 8, 2013 | TE: | AB | RLD: | No | ||||
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