Optimark

NDA 20937, held by Liebel-Flarsheim. Gadoversetamide.

As of Nov 13, 2026, NDA 20937 (Optimark), held by Liebel-Flarsheim, was first approved by FDA on Dec 8, 1999, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 8, 1999
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Aug 4, 2006	Supplement 9Efficacy (new indication or use)	Approved	Letter Label
Jan 31, 2003	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Dec 8, 1999	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Optimark1654.5MG/5ML (330.9MG/ML) · injectable;injection	Gadoversetamide	DiscontinuedReference drug
Optimark3309MG/10ML (330.9MG/ML) · injectable;injection	Gadoversetamide	DiscontinuedReference drug
Optimark4963.5MG/15ML (330.9MG/ML) · injectable;injection	Gadoversetamide	DiscontinuedReference drug
Optimark6618MG/20ML (330.9MG/ML) · injectable;injection	Gadoversetamide	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 28Labeling · Standard review	Approved	Letter Label Medication Guide
Apr 26, 2018	Supplement 27Labeling · Standard review	Approved	Letter Label Medication Guide
Aug 29, 2016	Supplement 26Labeling · Standard review	Approved	Label
Mar 14, 2016	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 24, 2014	Supplement 24Labeling	Approved	Label Letter
Aug 7, 2014	Supplement 23Labeling · Standard review	Approved	Letter Label
Aug 26, 2013	Supplement 22Labeling · Standard review	Approved	Label Letter
May 21, 2013	Supplement 21Labeling · Standard review	Approved	Letter Label
May 6, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 12, 2012	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 20, 2010	Supplement 16Labeling	Approved	Letter Label
Sep 4, 2007	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 4, 2006	Supplement 9Efficacy (new indication or use)	Approved	Letter Label
Nov 23, 2005	Supplement 7Manufacturing · Standard review	Approved	Letter
Jan 31, 2003	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Jan 29, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 8, 1999	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20937
Drugs@FDA: Overview at FDA
Company: Liebel-Flarsheim Company

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