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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 205792

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NDA 205792 describes ENTACAPONE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, 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. Fifteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.

Summary for 205792

Tradename:	ENTACAPONE
Applicant:	Ajanta Pharma Ltd
Ingredient:	entacapone
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 205792

Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Suppliers and Packaging for NDA: 205792

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTACAPONE	entacapone	TABLET;ORAL	205792	ANDA	Ajanta Pharma USA Inc.	27241-049	27241-049-10	100 TABLET in 1 BOTTLE (27241-049-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 31, 2017	TE:	AB	RLD:	No

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