← FDA DRUG APPROVALS

FDA NDA · NDA020937

OPTIMARK

Sponsor: LIEBEL-FLARSHEIM

APPLICATION
NDA020937
TYPE
NDA
ORIGINAL APPROVAL
1999-12-08
LATEST ACTION
2018-11-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OPTIMARK · ReferenceDiscontinued
GADOVERSETAMIDE 4963.5MG/15ML (330.9MG/ML) · INJECTABLE · INJECTION
OPTIMARK · ReferenceDiscontinued
GADOVERSETAMIDE 1654.5MG/5ML (330.9MG/ML) · INJECTABLE · INJECTION
OPTIMARK · ReferenceDiscontinued
GADOVERSETAMIDE 6618MG/20ML (330.9MG/ML) · INJECTABLE · INJECTION
OPTIMARK · ReferenceDiscontinued
GADOVERSETAMIDE 3309MG/10ML (330.9MG/ML) · INJECTABLE · INJECTION

Approval history

2018-11-02Labeling · Supplement 28 · standard — Label ↗AP
2018-04-26Labeling · Supplement 27 · standard — Label ↗AP
2016-08-29Labeling · Supplement 26 · standard — Label ↗AP
2016-03-14Manufacturing (CMC) · Supplement 25 · standardAP
2014-11-24Labeling · Supplement 24 · unknown — Label ↗AP
2014-08-07Labeling · Supplement 23 · standard — Letter ↗AP
2013-08-26Labeling · Supplement 22 · standard — Label ↗AP
2013-05-21Labeling · Supplement 21 · standard — Label ↗AP
2013-05-06Manufacturing (CMC) · Supplement 20 · standardAP
2012-12-12Manufacturing (CMC) · Supplement 19 · standardAP
2010-12-20Labeling · Supplement 16 · unknown — Label ↗AP
2007-09-04Labeling · Supplement 11 · standard — Label ↗AP
2006-08-04Efficacy · Supplement 9 · unknown — Letter ↗AP
2005-11-23Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2003-01-31Efficacy · Supplement 3 · standard — Review ↗AP
2001-01-29Manufacturing (CMC) · Supplement 2 · standardAP
1999-12-08Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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