FDA NDA · NDA018956

OMNIPAQUE

iohexol

Sponsor: GE HEALTHCARE

APPLICATION

NDA018956

TYPE

NDA

ORIGINAL APPROVAL

1985-12-26

LATEST ACTION

2024-10-08

ROUTE

INTRAVASCULAR, INTRAVENOUS, INTRATHECAL, ORAL, RECTAL, INTRA-ARTICULAR, INJECTION, INJECTION, ORAL, RECTAL, INJECTION, ORAL, URETHRAL

DOSAGE FORM

INJECTABLE, SOLUTION

MARKETING STATUS

Prescription, Discontinued

Products

OMNIPAQUE 140 · ReferencePrescription

IOHEXOL 30.2% · INJECTABLE · INJECTION

OMNIPAQUE 300 · ReferencePrescription

IOHEXOL 64.7% · SOLUTION · INJECTION, ORAL, RECTAL

OMNIPAQUE 180 · ReferencePrescription

IOHEXOL 38.8% · SOLUTION · INJECTION, ORAL, RECTAL

OMNIPAQUE 9 · ReferencePrescription

IOHEXOL 1.9% · SOLUTION · ORAL

OMNIPAQUE 210Discontinued

IOHEXOL 45.3% · INJECTABLE · INJECTION

OMNIPAQUE 350 · ReferencePrescription

IOHEXOL 75.5% · SOLUTION · INJECTION, ORAL

OMNIPAQUE 240 · ReferencePrescription

IOHEXOL 51.8% · SOLUTION · INJECTION, ORAL, RECTAL

OMNIPAQUE 12 · ReferencePrescription

IOHEXOL 2.6% · SOLUTION · ORAL

OMNIPAQUE 70Discontinued

IOHEXOL 15.1% · SOLUTION · URETHRAL

Approval history

2024-10-08Labeling · Supplement 119 · standard — Letter ↗AP

2023-04-25Labeling · Supplement 116 · standard — Letter ↗AP

2022-02-18Labeling · Supplement 113 · standard — Letter ↗AP

2021-08-05Labeling · Supplement 112 · standard — Label ↗AP

2020-11-04Labeling · Supplement 108 · standard — Letter ↗AP

2020-07-02Labeling · Supplement 105 · standard — Label ↗AP

2018-04-17Labeling · Supplement 101 · standard — Label ↗AP

2017-04-05Labeling · Supplement 99 · standard — Label ↗AP

2015-10-21Manufacturing (CMC) · Supplement 96 · standardAP

2015-07-06Labeling · Supplement 95 · standard — Letter ↗AP

2015-03-03Manufacturing (CMC) · Supplement 94 · standardAP

2014-06-19Manufacturing (CMC) · Supplement 93 · standardAP

2014-02-10Manufacturing (CMC) · Supplement 91 · standardAP

2013-11-20Manufacturing (CMC) · Supplement 92 · standardAP

2013-08-21Manufacturing (CMC) · Supplement 89 · standardAP

2007-10-01Labeling · Supplement 76 · standard — Letter ↗AP

2005-03-25Manufacturing (CMC) · Supplement 65 · standard — Letter ↗AP

2004-12-27Labeling · Supplement 62 · standard — Letter ↗AP

2004-03-05Labeling · Supplement 58 · standard — Letter ↗AP

2002-12-23Labeling · Supplement 49 · standard — Letter ↗AP

2002-12-23Labeling · Supplement 39 — Letter ↗AP

2002-11-20Manufacturing (CMC) · Supplement 54 · standardAP

2002-08-05Manufacturing (CMC) · Supplement 53 · standardAP

2000-12-19Manufacturing (CMC) · Supplement 52 · standardAP

1998-09-08Manufacturing (CMC) · Supplement 51 · standardAP

1995-12-04Manufacturing (CMC) · Supplement 30 · standardAP

1995-11-28Manufacturing (CMC) · Supplement 42 · standardAP

1995-08-18Manufacturing (CMC) · Supplement 46 · standardAP

1995-08-18Manufacturing (CMC) · Supplement 44 · standardAP

1995-06-15Labeling · Supplement 43 · standard — Review ↗AP

1994-11-04Manufacturing (CMC) · Supplement 45 · standardAP

1994-09-30Manufacturing (CMC) · Supplement 41 · standardAP

1994-06-01Manufacturing (CMC) · Supplement 35 · standardAP

1994-06-01Labeling · Supplement 36AP

1993-12-23Manufacturing (CMC) · Supplement 8 · standardAP

1993-07-13Efficacy · Supplement 28 — Review ↗AP

1993-03-01Labeling · Supplement 33AP

1993-03-01Manufacturing (CMC) · Supplement 31 · standardAP

1993-03-01Manufacturing (CMC) · Supplement 34 · standardAP

1993-03-01Manufacturing (CMC) · Supplement 32 · standardAP

VIEW ON DRUGS@FDA ↗

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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Approval history

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