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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 203437

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NDA 203437 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 203437

Tradename:	ENTACAPONE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	entacapone
Patents:	0

Pharmacology for NDA: 203437

Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Suppliers and Packaging for NDA: 203437

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTACAPONE	entacapone	TABLET;ORAL	203437	ANDA	Major Pharmaceuticals	0904-6822	0904-6822-07	30 BLISTER PACK in 1 CARTON (0904-6822-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ENTACAPONE	entacapone	TABLET;ORAL	203437	ANDA	AvPAK	50268-295	50268-295-15	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-295-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-295-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jun 19, 2015	TE:	AB	RLD:	No

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