FDA NDA · NDA020808

VISIPAQUE

iodixanol

Sponsor: GE HEALTHCARE

APPLICATION

NDA020808

TYPE

NDA

ORIGINAL APPROVAL

1997-08-29

LATEST ACTION

2023-04-25

ROUTE

INTRAVASCULAR, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued, Prescription

Products

VISIPAQUE 270Discontinued

IODIXANOL 55% · INJECTABLE · INJECTION

VISIPAQUE 320Prescription

IODIXANOL 65.2% · INJECTABLE · INJECTION

2023-04-25Labeling · Supplement 35 · standard — Letter ↗AP

2022-02-18Labeling · Supplement 32 · standard — Label ↗AP

2019-03-12Labeling · Supplement 28 · standard — Label ↗AP

2017-04-05Efficacy · Supplement 25 · priority — Label ↗AP

2017-04-05Labeling · Supplement 26 · standard — Label ↗AP

2015-07-06Labeling · Supplement 24 · standard — Label ↗AP

2013-01-18Manufacturing (CMC) · Supplement 20 · standardAP

2003-12-18Labeling · Supplement 4 · standard — Letter ↗AP

2003-09-04Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP

1999-01-28Labeling · Supplement 1 · standard — Review ↗AP

1997-08-29Type 3 - New Dosage Form · Original · standardAP

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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