← FDA DRUG APPROVALS

FDA NDA · NDA020220

ULTRAVIST

iopromide

Sponsor: BAYER HLTHCARE

APPLICATION
NDA020220
TYPE
NDA
ORIGINAL APPROVAL
1995-05-10
LATEST ACTION
2023-06-15
ROUTE
INTRA-ARTERIAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

ULTRAVIST 150 · ReferenceDiscontinued
IOPROMIDE 31.2% · INJECTABLE · INJECTION
ULTRAVIST 300 · ReferencePrescription
IOPROMIDE 62.3% · INJECTABLE · INJECTION
ULTRAVIST 300 IN PLASTIC CONTAINER · ReferenceDiscontinued
IOPROMIDE 62.3% · INJECTABLE · INJECTION
ULTRAVIST 240 · ReferenceDiscontinued
IOPROMIDE 49.9% · INJECTABLE · INJECTION
ULTRAVIST 370 · ReferencePrescription
IOPROMIDE 76.9% · INJECTABLE · INJECTION

Approval history

2023-06-15Labeling · Supplement 55 · standard — Label ↗AP
2023-05-25Efficacy · Supplement 54 · standard — Letter ↗AP
2023-04-25Labeling · Supplement 56 · standard — Label ↗AP
2022-02-18Labeling · Supplement 52 · standard — Letter ↗AP
2019-08-01Labeling · Supplement 47 · standard — Label ↗AP
2018-04-24Labeling · Supplement 46 · standard — Label ↗AP
2018-04-02Labeling · Supplement 45 · standard — Letter ↗AP
2017-07-27Labeling · Supplement 43 · standard — Label ↗AP
2017-04-05Labeling · Supplement 42 · standard — Label ↗AP
2015-07-06Labeling · Supplement 41 · standard — Label ↗AP
2013-07-29Manufacturing (CMC) · Supplement 40 · standardAP
2012-05-02Labeling · Supplement 36 · standard — Label ↗AP
2009-12-30Efficacy · Supplement 33 · standard — Label ↗AP
2009-11-13Manufacturing (CMC) · Supplement 35 · standard — Letter ↗AP
2007-08-31Labeling · Supplement 27 · standard — Letter ↗AP
2005-08-12Labeling · Supplement 22 · standard — Letter ↗AP
2004-03-12Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
2003-04-25Labeling · Supplement 8 · standard — Letter ↗AP
2002-10-30Manufacturing (CMC) · Supplement 14 · standardAP
2002-04-11Manufacturing (CMC) · Supplement 13 · standardAP
2001-11-05Manufacturing (CMC) · Supplement 12 · standardAP
2001-01-04Manufacturing (CMC) · Supplement 11 · standardAP
2000-10-24Manufacturing (CMC) · Supplement 10 · standardAP
2000-09-27Manufacturing (CMC) · Supplement 9 · standardAP
1999-12-27Manufacturing (CMC) · Supplement 7 · standardAP
1998-11-25Manufacturing (CMC) · Supplement 6 · standardAP
1998-11-03Manufacturing (CMC) · Supplement 5 · standardAP
1997-07-23Efficacy · Supplement 2 · unknownAP
1997-06-05Manufacturing (CMC) · Supplement 4 · standardAP
1995-05-30Labeling · Supplement 1 · standardAP
1995-05-10Type 1 - New Molecular Entity · 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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