Comtan

NDA 20796, held by Orion Pharma. Entacapone.

As of Nov 13, 2026, NDA 20796 (Comtan), held by Orion Pharma, was first approved by FDA on Oct 19, 1999, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 19, 1999
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone Tablets’ effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 19, 1999	Original applicationNew molecular entity · Standard review	Approved	Label Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Comtan200MG · tablet;oral	Entacapone	RxReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 22, 2016	Supplement 26Labeling · Standard review	Approved	Label Letter
Oct 16, 2015	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 16, 2015	Supplement 24Labeling · Standard review	Approved	Label Letter
Jun 13, 2014	Supplement 16Labeling · Standard review	Approved	Letter Label
Jan 16, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 11, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 11, 2010	Supplement 15Labeling · Standard review	Approved	Letter Label
Feb 2, 2009	Supplement 13Labeling · Standard review	Approved	Label Letter
Feb 2, 2009	Supplement 12Labeling · Standard review	Approved	Label Letter
Apr 18, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 17, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 10, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 14, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 19, 1999	Original applicationNew molecular entity · Standard review	Approved	Label Review Letter

Identifiers

Application: NDA 20796
Drugs@FDA: Overview at FDA
Company: Orion Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters