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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 020796

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NDA 020796 describes COMTAN, which is a drug marketed by Orion Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the COMTAN profile page.

The generic ingredient in COMTAN 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 020796

Tradename:	COMTAN
Applicant:	Orion Pharma
Ingredient:	entacapone
Patents:	0

Suppliers and Packaging for NDA: 020796

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COMTAN	entacapone	TABLET;ORAL	020796	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-5578	0781-5578-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)
COMTAN	entacapone	TABLET;ORAL	020796	NDA AUTHORIZED GENERIC	Sun Pharmaceutical Industries, Inc.	47335-007	47335-007-88	100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Oct 19, 1999	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020796

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	⤷ Get Started Free	⤷ Get Started Free
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	⤷ Get Started Free	⤷ Get Started Free
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	⤷ Get Started Free	⤷ Get Started Free
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	⤷ Get Started Free	⤷ Get Started Free
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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