Details for New Drug Application (NDA): 073618
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NDA 073618 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, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, SCS, Watson Labs, and Zydus Pharms, and is included in twenty-eight 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 073618
| Tradename: | CARBIDOPA AND LEVODOPA |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | carbidopa; levodopa |
| Patents: | 0 |
Suppliers and Packaging for NDA: 073618
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 073618 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8555 | 0615-8555-39 | 30 TABLET in 1 BLISTER PACK (0615-8555-39) |
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 073618 | ANDA | Mayne Pharma Commercial LLC | 51862-855 | 51862-855-01 | 100 TABLET in 1 BOTTLE (51862-855-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;100MG | ||||
| Approval Date: | Aug 28, 1992 | TE: | AB | RLD: | No | ||||
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