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Last Updated: March 15, 2026

Details for New Drug Application (NDA): 203261

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NDA 203261 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, 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-three NDAs. It is available from seven 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. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for 203261

Tradename:	CARBIDOPA
Applicant:	Ani Pharms
Ingredient:	carbidopa
Patents:	0

Medical Subject Heading (MeSH) Categories for 203261

Antiparkinson Agents
Aromatic Amino Acid Decarboxylase Inhibitors
Dopamine Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 10, 2014	TE:		RLD:	No

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