Tasmar

Treats idiopathic Parkinson's disease. NDA 20697, held by Bausch. Tolcapone.

As of Nov 13, 2026, NDA 20697 (Tasmar), held by Bausch, was first approved by FDA on Jan 29, 1998, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1998
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS: TASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jan 29, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Tasmar100MG · tablet;oral	Tolcapone	DiscontinuedReference drug
Tasmar200MG · tablet;oral	Tolcapone	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 30, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
May 11, 2013	Supplement 4Labeling · Standard review	Approved	Letter Label
Apr 30, 2013	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 30, 2009	Supplement 16Manufacturing	Approved	Letter
Feb 9, 2009	Supplement 15Labeling · Standard review	Approved	Letter Label
Feb 9, 2009	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 24, 2007	Supplement 12Labeling · Standard review	Approved	Letter Label
Feb 17, 2006	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 24, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 22, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 16, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Apr 24, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 29, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20697
Drugs@FDA: Overview at FDA
Company: Bausch Health

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