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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204291

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NDA 204291 describes CARBIDOPA, which is a drug marketed by Alvogen, Ani Pharms, Aurobindo Pharma, Edenbridge Pharms, Novel Labs Inc, Regcon Holdings, Zydus Pharms, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon Research, Sciegen Pharms Inc, Sun Pharm Inds, Rising, Sun Pharm, Actavis Elizabeth, Apotex Inc, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pharmobedient, SCS, Watson Labs, Macleods Pharms Ltd, and Wockhardt Ltd, and is included in forty-two 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. Four suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for 204291

Tradename:	CARBIDOPA
Applicant:	Alvogen
Ingredient:	carbidopa
Patents:	0

Medical Subject Heading (MeSH) Categories for 204291

Antiparkinson Agents
Aromatic Amino Acid Decarboxylase Inhibitors
Dopamine Agents

Suppliers and Packaging for NDA: 204291

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBIDOPA	carbidopa	TABLET;ORAL	204291	ANDA	Alvogen Inc.	47781-332	47781-332-01	100 TABLET in 1 BOTTLE (47781-332-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jan 8, 2016	TE:		RLD:	No

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