Details for New Drug Application (NDA): 078536
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NDA 078536 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-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-five 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-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 078536
| Tradename: | CARBIDOPA AND LEVODOPA |
| Applicant: | Sun Pharm Inds |
| Ingredient: | carbidopa; levodopa |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078536
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 078536 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-517 | 62756-517-08 | 100 TABLET in 1 BOTTLE (62756-517-08) |
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 078536 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-517 | 62756-517-13 | 500 TABLET in 1 BOTTLE (62756-517-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;100MG | ||||
| Approval Date: | Oct 28, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Oct 28, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;250MG | ||||
| Approval Date: | Oct 28, 2008 | TE: | AB | RLD: | No | ||||
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