← FDA DRUG APPROVALS

FDA NDA · NDA021489

PROHANCE

gadoteridol

Sponsor: BRACCO

APPLICATION
NDA021489
TYPE
NDA
ORIGINAL APPROVAL
2003-10-09
LATEST ACTION
2025-03-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PROHANCE MULTIPACK · ReferencePrescription
GADOTERIDOL 279.3MG/ML · INJECTABLE · INJECTION

Approval history

2025-03-05Labeling · Supplement 25 · standard — Letter ↗AP
2024-08-14Labeling · Supplement 23 · standard — Label ↗AP
2024-07-23Labeling · Supplement 24 · standard — Label ↗AP
2024-01-26Labeling · Supplement 21 · standard — Label ↗AP
2022-11-19Labeling · Supplement 18 · standard — Letter ↗AP
2021-05-06Labeling · Supplement 16 · standard — Letter ↗AP
2020-12-19Efficacy · Supplement 14 · standard — Letter ↗AP
2018-11-02Labeling · Supplement 10 · standard — Label ↗AP
2018-04-26Labeling · Supplement 6 · standard — Label ↗AP
2017-09-15Labeling · Supplement 5 · standard — Label ↗AP
2014-07-22Labeling · Supplement 4 · standard — Letter ↗AP
2013-08-13Labeling · Supplement 3 · standard — Label ↗AP
2010-12-20Labeling · Supplement 2 · unknown — Letter ↗AP
2007-09-04Labeling · Supplement 1 · standard — Label ↗AP
2003-10-09Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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