Last Updated: June 4, 2026

Details for New Drug Application (NDA): 206669

✉ Email this page to a colleague

« Back to Dashboard

NDA 206669 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 eleven 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 206669

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

Pharmacology for NDA: 206669

Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Suppliers and Packaging for NDA: 206669

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTACAPONE	entacapone	TABLET;ORAL	206669	ANDA	Lannett Company, Inc.	0527-1830	0527-1830-37	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-37)
ENTACAPONE	entacapone	TABLET;ORAL	206669	ANDA	Rising Pharma Holdings, Inc.	64980-722	64980-722-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-722-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Oct 3, 2018	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.