Details for New Drug Application (NDA): 204763
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NDA 204763 describes CARBIDOPA, which is a drug marketed by Alvogen, Ani Pharms, Aurobindo Pharma, Beximco Pharms Usa, Edenbridge Pharms, Novel Labs Inc, Zydus Pharms, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon, Sciegen Pharms Inc, Sun Pharm Inds, Rising, Sun Pharm, Actavis Elizabeth, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, SCS, Watson Labs, Norvium Bioscience, and Wockhardt Ltd, and is included in forty NDAs. It is available from eight suppliers. Additional details are available on the CARBIDOPA profile page.
The generic ingredient in CARBIDOPA is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
The generic ingredient in CARBIDOPA is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
Summary for 204763
| Tradename: | CARBIDOPA |
| Applicant: | Novel Labs Inc |
| Ingredient: | carbidopa |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 204763
Suppliers and Packaging for NDA: 204763
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA | carbidopa | TABLET;ORAL | 204763 | ANDA | Novel Laboratories, Inc. | 40032-980 | 40032-980-01 | 100 TABLET in 1 BOTTLE (40032-980-01) |
| CARBIDOPA | carbidopa | TABLET;ORAL | 204763 | ANDA | Novel Laboratories, Inc. | 40032-980 | 40032-980-03 | 30 TABLET in 1 BOTTLE (40032-980-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 20, 2017 | TE: | AB | RLD: | No | ||||
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