Last Updated: November 13, 2026

Details for New Drug Application (NDA): 078941

NDA 078941 describes ENTACAPONE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms, Pharmobedient, Sun Pharm, Sunshine, and Wockhardt Bio Ag, and is included in eight NDAs. It is available from eleven suppliers. Additional details are available on the ENTACAPONE profile page.

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

Summary for 078941

Tradename:	ENTACAPONE
Applicant:	Wockhardt Bio Ag
Ingredient:	entacapone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 16, 2012	TE:	AB	RLD:	No

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