← FDA DRUG APPROVALS

FDA NDA · NDA020608

OMNIPAQUE

iohexol

Sponsor: GE HEALTHCARE

APPLICATION
NDA020608
TYPE
NDA
ORIGINAL APPROVAL
1995-10-24
LATEST ACTION
2024-10-08
ROUTE
INTRAVENOUS, INJECTION, ORAL, INJECTION, ORAL, RECTAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

OMNIPAQUE 350Prescription
IOHEXOL 75.5% · SOLUTION · INJECTION, ORAL
OMNIPAQUE 240Discontinued
IOHEXOL 51.8% · SOLUTION · INJECTION, ORAL, RECTAL
OMNIPAQUE 300Prescription
IOHEXOL 64.7% · SOLUTION · INJECTION, ORAL, RECTAL

Approval history

2024-10-08Labeling · Supplement 47 · standard — Letter ↗AP
2023-04-25Labeling · Supplement 49 · standard — Letter ↗AP
2022-02-18Labeling · Supplement 45 · standard — Letter ↗AP
2017-11-09Labeling · Supplement 38 · standard — Letter ↗AP
2017-04-05Labeling · Supplement 37 · standard — Label ↗AP
2017-04-05Labeling · Supplement 36 · standard — Label ↗AP
2016-12-21Labeling · Supplement 34 · standard — Label ↗AP
2015-07-06Labeling · Supplement 31 · standard — Label ↗AP
2007-10-01Labeling · Supplement 18 · standard — Letter ↗AP
2004-03-05Labeling · Supplement 9 · standard — Letter ↗AP
2004-02-13Labeling · Supplement 10 · standard — Letter ↗AP
2002-11-20Manufacturing (CMC) · Supplement 5 · standardAP
2002-08-05Manufacturing (CMC) · Supplement 4 · standardAP
2000-12-19Manufacturing (CMC) · Supplement 3 · standardAP
1998-03-10Labeling · Supplement 1 · standardAP
1997-06-04Manufacturing (CMC) · Supplement 2 · standardAP
1995-10-24Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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