← FDA DRUG APPROVALS

FDA NDA · NDA021425

ULTRAVIST (PHARMACY BULK)

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021425
TYPE
NDA
ORIGINAL APPROVAL
2002-09-20
LATEST ACTION
2023-06-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

ULTRAVIST (PHARMACY BULK) · ReferencePrescription
IOPROMIDE 62.3% · INJECTABLE · INJECTION
ULTRAVIST (PHARMACY BULK) · ReferencePrescription
IOPROMIDE 76.9% · INJECTABLE · INJECTION
ULTRAVIST (PHARMACY BULK) · ReferenceDiscontinued
IOPROMIDE 49.9% · INJECTABLE · INJECTION

Approval history

2023-06-15Labeling · Supplement 37 · standard — Label ↗AP
2023-05-25Efficacy · Supplement 36 · standard — Letter ↗AP
2023-04-25Labeling · Supplement 38 · standard — Label ↗AP
2022-02-18Labeling · Supplement 34 · standard — Letter ↗AP
2019-08-01Labeling · Supplement 30 · standard — Label ↗AP
2018-05-04Manufacturing (CMC) · Supplement 29 — Letter ↗AP
2018-04-02Labeling · Supplement 28 · standard — Label ↗AP
2017-04-05Labeling · Supplement 26 · standard — Label ↗AP
2016-11-17Manufacturing (CMC) · Supplement 25 · standardAP
2015-07-06Labeling · Supplement 24 · standard — Letter ↗AP
2012-05-02Labeling · Supplement 20 · standard — Label ↗AP
2010-06-23Efficacy · Supplement 17 · standard — Label ↗AP
2009-11-13Manufacturing (CMC) · Supplement 19 · standard — Letter ↗AP
2007-08-31Labeling · Supplement 12 · standard — Letter ↗AP
2004-03-12Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
2003-01-23Labeling · Supplement 1 · standard — Letter ↗AP
2002-09-20Type 3 - New Dosage Form · Original · standard — Letter ↗AP
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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