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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 078941

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NDA 078941 describes ENTACAPONE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Norvium Bioscience, 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. 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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