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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 214092


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NDA 214092 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 214092
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Sciegen Pharms Inc
Ingredient:carbidopa; levodopa
Patents:0
Pharmacology for NDA: 214092
Suppliers and Packaging for NDA: 214092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 214092 ANDA A-S Medication Solutions 50090-5969 50090-5969-1 90 TABLET in 1 BOTTLE (50090-5969-1)
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 214092 ANDA A-S Medication Solutions 50090-5969 50090-5969-2 270 TABLET in 1 BOTTLE (50090-5969-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;100MG
Approval Date:May 7, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:May 7, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;250MG
Approval Date:May 7, 2021TE:ABRLD:No

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