Details for New Drug Application (NDA): 075091
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NDA 075091 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Rising, Sun Pharm, Actavis Elizabeth, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rubicon, SCS, Watson Labs, and Zydus Pharms, and is included in twenty-seven NDAs. It is available from twenty-eight 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-two 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-two suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 075091
| Tradename: | CARBIDOPA AND LEVODOPA |
| Applicant: | Mylan |
| Ingredient: | carbidopa; levodopa |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075091
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 075091 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0088 | 0378-0088-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0088-01) |
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 075091 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0094 | 0378-0094-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0094-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG;200MG | ||||
| Approval Date: | Sep 30, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Apr 21, 2000 | TE: | AB | RLD: | No | ||||
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