Details for New Drug Application (NDA): 078893
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NDA 078893 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 are eighteen drug master file entries 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 are eighteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 078893
| Tradename: | CARBIDOPA AND LEVODOPA |
| Applicant: | Rising |
| Ingredient: | carbidopa; levodopa |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078893
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, ORALLY DISINTEGRATING;ORAL | 078893 | ANDA | Rising Pharma Holdings, Inc. | 16571-157 | 16571-157-01 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-157-01) |
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, ORALLY DISINTEGRATING;ORAL | 078893 | ANDA | Rising Pharma Holdings, Inc. | 16571-158 | 16571-158-01 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-158-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG;100MG | ||||
| Approval Date: | Sep 18, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Sep 18, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 25MG;250MG | ||||
| Approval Date: | Sep 18, 2008 | TE: | AB | RLD: | No | ||||
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