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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 076212


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NDA 076212 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Apotex, Impax Labs, Kv Pharm, Mylan, Sun Pharm Inds, Sun Pharm, Actavis Elizabeth, Ani Pharms, Apotex Inc, Mayne Pharma, Sciegen Pharms Inc, SCS, and Watson Labs, and is included in twenty-three NDAs. It is available from twenty-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. Twenty-six suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 076212
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Apotex
Ingredient:carbidopa; levodopa
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG;100MG
Approval Date:Jun 16, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;200MG
Approval Date:Jun 16, 2004TE:ABRLD:No

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