← FDA DRUG APPROVALS

FDA NDA · NDA022066

OMNISCAN

Sponsor: GE HEALTHCARE

APPLICATION
NDA022066
TYPE
NDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2025-03-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OMNISCAN · ReferenceDiscontinued
GADODIAMIDE 14.35GM/50ML (287MG/ML) · INJECTABLE · INJECTION
OMNISCAN · ReferenceDiscontinued
GADODIAMIDE 28.7GM/100ML (287MG/ML) · INJECTABLE · INJECTION

Approval history

2025-03-05Labeling · Supplement 15 · standard — Letter ↗AP
2024-08-14Labeling · Supplement 12 · standard — Letter ↗AP
2024-07-23Labeling · Supplement 14 · standard — Label ↗AP
2024-01-26Labeling · Supplement 13 · standard — Label ↗AP
2019-10-23Labeling · Supplement 10 · standard — Letter ↗AP
2018-11-07Labeling · Supplement 9 · standard — Label ↗AP
2018-04-26Labeling · Supplement 8 · standard — Label ↗AP
2014-11-14Labeling · Supplement 7 · standard — Letter ↗AP
2014-05-14Manufacturing (CMC) · Supplement 5AP
2013-08-27Labeling · Supplement 4 · standard — Letter ↗AP
2012-12-11Labeling · Supplement 6 · standard — Letter ↗AP
2010-12-20Labeling · Supplement 2 · unknown — Label ↗AP
2007-09-05Type 5 - New Formulation or New Manufacturer · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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