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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 212601

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NDA 212601 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 212601

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

Pharmacology for NDA: 212601

Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Suppliers and Packaging for NDA: 212601

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTACAPONE	entacapone	TABLET;ORAL	212601	ANDA	Alembic Pharmaceuticals Limited	46708-478	46708-478-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31)
ENTACAPONE	entacapone	TABLET;ORAL	212601	ANDA	Alembic Pharmaceuticals Limited	46708-478	46708-478-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 4, 2022	TE:	AB	RLD:	No

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