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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207210

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NDA 207210 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 207210

Tradename:	ENTACAPONE
Applicant:	Macleods Pharms Ltd
Ingredient:	entacapone
Patents:	0

Pharmacology for NDA: 207210

Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Suppliers and Packaging for NDA: 207210

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTACAPONE	entacapone	TABLET;ORAL	207210	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8298	0615-8298-39	30 TABLET in 1 BLISTER PACK (0615-8298-39)
ENTACAPONE	entacapone	TABLET;ORAL	207210	ANDA	Macleods Pharmaceuticals Limited	33342-260	33342-260-11	100 TABLET in 1 BOTTLE (33342-260-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jun 5, 2017	TE:	AB	RLD:	No

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