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FDA NDA · NDA018735

ISOVUE 200

iopamidol

Sponsor: BRACCO

APPLICATION
NDA018735
TYPE
NDA
ORIGINAL APPROVAL
1985-12-31
LATEST ACTION
2026-01-13
ROUTE
INTRAVASCULAR, INTRATHECAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

ISOVUE-250 · ReferencePrescription
IOPAMIDOL 51% · INJECTABLE · INJECTION
ISOVUE-128Discontinued
IOPAMIDOL 26% · INJECTABLE · INJECTION
ISOVUE-370 · ReferencePrescription
IOPAMIDOL 76% · INJECTABLE · INJECTION
ISOVUE-M 200 · ReferencePrescription
IOPAMIDOL 41% · INJECTABLE · INJECTION
ISOVUE-200 · ReferencePrescription
IOPAMIDOL 41% · INJECTABLE · INJECTION
ISOVUE-M 300 · ReferencePrescription
IOPAMIDOL 61% · INJECTABLE · INJECTION
ISOVUE-300 · ReferencePrescription
IOPAMIDOL 61% · INJECTABLE · INJECTION

Approval history

2026-01-13Labeling · Supplement 74 · standard — Letter ↗AP
2025-10-10Labeling · Supplement 76 · standard — Letter ↗AP
2025-10-10Efficacy · Supplement 75 · standard — Letter ↗AP
2024-12-06Labeling · Supplement 73 · standard — Letter ↗AP
2023-04-25Labeling · Supplement 70 · standard — Label ↗AP
2022-02-18Labeling · Supplement 67 · standard — Letter ↗AP
2017-04-05Labeling · Supplement 57 · standard — Label ↗AP
2015-07-06Labeling · Supplement 56 · standard — Letter ↗AP
2015-05-14Manufacturing (CMC) · Supplement 55 · standardAP
2012-08-01Labeling · Supplement 54 · standard — Letter ↗AP
2006-03-10Manufacturing (CMC) · Supplement 51 · standardAP
2005-12-01Manufacturing (CMC) · Supplement 49 · standardAP
2005-07-26Manufacturing (CMC) · Supplement 50 · standardAP
2003-10-07Manufacturing (CMC) · Supplement 48 · standardAP
2002-07-08Labeling · Supplement 43 · standard — Letter ↗AP
2002-06-20Labeling · Supplement 44 · standard — Letter ↗AP
2000-06-01Manufacturing (CMC) · Supplement 47 · standardAP
1999-12-09Manufacturing (CMC) · Supplement 46 · standardAP
1999-11-16Manufacturing (CMC) · Supplement 45 · standardAP
1997-05-14Manufacturing (CMC) · Supplement 41 · standardAP
1997-03-19Manufacturing (CMC) · Supplement 40 · standardAP
1996-06-24Manufacturing (CMC) · Supplement 39 · standardAP
1996-03-04Efficacy · Supplement 33 · unknownAP
1995-09-29Labeling · Supplement 38 · standardAP
1995-05-15Labeling · Supplement 37 · standardAP
1995-05-15Efficacy · Supplement 36 · standardAP
1994-03-21Manufacturing (CMC) · Supplement 35 · standardAP
1993-09-09Manufacturing (CMC) · Supplement 34 · standardAP
1992-12-21Manufacturing (CMC) · Supplement 32 · standardAP
1992-09-30Labeling · Supplement 29AP
1992-09-30Manufacturing (CMC) · Supplement 28 · standardAP
1992-07-06Efficacy · Supplement 25AP
1991-07-29Labeling · Supplement 24AP
1991-01-03Manufacturing (CMC) · Supplement 22 · standardAP
1990-11-27Manufacturing (CMC) · Supplement 19 · standardAP
1990-11-19Manufacturing (CMC) · Supplement 18 · standardAP
1990-09-21Efficacy · Supplement 23AP
1990-05-30Efficacy · Supplement 21AP
1990-01-18Efficacy · Supplement 10AP
1989-10-04Efficacy · Supplement 12AP
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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