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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 079085

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NDA 079085 describes CARBIDOPA, LEVODOPA AND ENTACAPONE, which is a drug marketed by Macleods Pharms Ltd, Pharmobedient, Rising, Sun Pharm, and Wockhardt Ltd, and is included in six NDAs. It is available from two suppliers. Additional details are available on the CARBIDOPA, LEVODOPA AND ENTACAPONE profile page.

The generic ingredient in CARBIDOPA, LEVODOPA AND ENTACAPONE 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 079085

Tradename:	CARBIDOPA, LEVODOPA AND ENTACAPONE
Applicant:	Sun Pharm
Ingredient:	carbidopa; entacapone; levodopa
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;200MG;100MG
Approval Date:	May 10, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	37.5MG;200MG;150MG
Approval Date:	May 10, 2012	TE:		RLD:	No

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