← FDA DRUG APPROVALS

FDA NDA · NDA020123

OMNISCAN

gadodiamide

Sponsor: GE HEALTHCARE

APPLICATION
NDA020123
TYPE
NDA
ORIGINAL APPROVAL
1993-01-08
LATEST ACTION
2025-03-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

OMNISCAN · ReferencePrescription
GADODIAMIDE 287MG/ML · INJECTABLE · INJECTION

Approval history

2025-03-05Labeling · Supplement 52 · standard — Letter ↗AP
2024-08-14Labeling · Supplement 49 · standard — Letter ↗AP
2024-07-23Labeling · Supplement 51 · standard — Label ↗AP
2024-01-26Labeling · Supplement 50 · standard — Label ↗AP
2018-11-07Labeling · Supplement 47 · standard — Label ↗AP
2018-04-26Labeling · Supplement 46 · standard — Label ↗AP
2016-06-06Manufacturing (CMC) · Supplement 44 · standardAP
2014-11-14Labeling · Supplement 43 · standard — Letter ↗AP
2014-06-23Manufacturing (CMC) · Supplement 42 · standardAP
2014-05-14Manufacturing (CMC) · Supplement 40AP
2014-04-03Manufacturing (CMC) · Supplement 41 · standardAP
2013-08-27Labeling · Supplement 39 · standard — Label ↗AP
2010-12-20Labeling · Supplement 37 · unknown — Label ↗AP
2007-12-14Labeling · Supplement 35 · standard — Label ↗AP
2007-09-05Labeling · Supplement 34 · standard — Letter ↗AP
2002-11-15Manufacturing (CMC) · Supplement 23 · standard — Letter ↗AP
2002-08-12Manufacturing (CMC) · Supplement 24 · standardAP
2002-07-08Labeling · Supplement 18 · standard — Letter ↗AP
2002-06-28Labeling · Supplement 22 · standard — Letter ↗AP
2002-05-20Manufacturing (CMC) · Supplement 21 · standard — Letter ↗AP
2002-03-15Manufacturing (CMC) · Supplement 20 · standardAP
2001-07-30Manufacturing (CMC) · Supplement 19 · standardAP
2001-03-13Manufacturing (CMC) · Supplement 17 · standardAP
2001-01-17Manufacturing (CMC) · Supplement 16 · standardAP
1997-10-03Labeling · Supplement 15 · standard — Review ↗AP
1997-03-27Manufacturing (CMC) · Supplement 13 · standardAP
1997-03-19Manufacturing (CMC) · Supplement 14 · standardAP
1996-02-05Efficacy · Supplement 4 · unknownAP
1996-02-05Efficacy · Supplement 7 · standardAP
1996-02-05Efficacy · Supplement 5 · standardAP
1995-02-17Manufacturing (CMC) · Supplement 9 · standardAP
1994-11-04Manufacturing (CMC) · Supplement 2 · standardAP
1994-06-06Manufacturing (CMC) · Supplement 3 · standardAP
1993-04-26Manufacturing (CMC) · Supplement 1 · standardAP
1993-01-08Type 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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