← FDA DRUG APPROVALS

FDA NDA · NDA020327

ISOVUE 300

iopamidol

Sponsor: BRACCO

APPLICATION
NDA020327
TYPE
NDA
ORIGINAL APPROVAL
1994-10-12
LATEST ACTION
2026-01-13
ROUTE
INTRAVASCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

ISOVUE-370 · ReferencePrescription
IOPAMIDOL 76% · INJECTABLE · INJECTION
ISOVUE-250 · ReferenceDiscontinued
IOPAMIDOL 51% · INJECTABLE · INJECTION
ISOVUE-300 · ReferencePrescription
IOPAMIDOL 61% · INJECTABLE · INJECTION
ISOVUE-200Discontinued
IOPAMIDOL 41% · INJECTABLE · INJECTION

Approval history

2026-01-13Labeling · Supplement 28 · standard — Letter ↗AP
2023-04-25Labeling · Supplement 25 · standard — Label ↗AP
2022-02-18Labeling · Supplement 23 · standard — Letter ↗AP
2018-02-16Labeling · Supplement 14 · standard — Label ↗AP
2017-04-05Labeling · Supplement 12 · standard — Label ↗AP
2016-01-22Labeling · Supplement 11 · standard — Letter ↗AP
2015-07-06Labeling · Supplement 10 · standard — Letter ↗AP
2014-06-20Labeling · Supplement 8 · standard — Letter ↗AP
2012-08-01Labeling · Supplement 7 · standard — Label ↗AP
2005-07-26Manufacturing (CMC) · Supplement 5 · standardAP
2003-12-05Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2002-06-20Labeling · Supplement 2 · standard — Letter ↗AP
1999-12-09Manufacturing (CMC) · Supplement 3 · standardAP
1996-12-17Manufacturing (CMC) · Supplement 1 · standardAP
1994-10-12Type 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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