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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 202394

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NDA 202394 describes ENTACAPONE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Pharmobedient, Sun Pharm, Sunshine, and Wockhardt Bio Ag, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the ENTACAPONE profile page.

The generic ingredient in ENTACAPONE is entacapone. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.

Summary for 202394

Tradename:	ENTACAPONE
Applicant:	Pharmobedient
Ingredient:	entacapone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 13, 2013	TE:		RLD:	No

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