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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 202323


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NDA 202323 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.
Summary for 202323
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Accord Hlthcare
Ingredient:carbidopa; levodopa
Patents:0
Pharmacology for NDA: 202323
Suppliers and Packaging for NDA: 202323
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 202323 ANDA Accord Healthcare, Inc. 16729-078 16729-078-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-01)
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 202323 ANDA Accord Healthcare, Inc. 16729-078 16729-078-17 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG;100MG
Approval Date:Feb 8, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;200MG
Approval Date:Feb 8, 2013TE:ABRLD:No

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