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FDA NDA · NDA020131

PROHANCE

gadoteridol

Sponsor: BRACCO

APPLICATION
NDA020131
TYPE
NDA
ORIGINAL APPROVAL
1992-11-16
LATEST ACTION
2025-03-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2025-03-05Labeling · Supplement 44 · standard — Letter ↗AP
2024-08-14Labeling · Supplement 42 · standard — Label ↗AP
2024-07-23Labeling · Supplement 43 · standard — Label ↗AP
2024-01-26Labeling · Supplement 40 · standard — Label ↗AP
2022-11-28Labeling · Supplement 37 · standard — Letter ↗AP
2020-12-19Efficacy · Supplement 35 · standard — Letter ↗AP
2018-04-26Labeling · Supplement 28 · standard — Label ↗AP
2017-09-15Labeling · Supplement 27 · standard — Label ↗AP
2013-08-13Labeling · Supplement 26 · standard — Label ↗AP
2010-12-20Labeling · Supplement 24 · unknown — Letter ↗AP
2007-09-04Labeling · Supplement 23 · standard — Label ↗AP
2002-09-30Labeling · Supplement 9 · standard — Letter ↗AP
2002-09-30Labeling · Supplement 16 · standard — Letter ↗AP
2002-06-03Manufacturing (CMC) · Supplement 21 · standardAP
2001-07-19Manufacturing (CMC) · Supplement 19 · standardAP
2001-03-09Manufacturing (CMC) · Supplement 18 · standardAP
2001-01-24Manufacturing (CMC) · Supplement 17 · standardAP
1998-04-02Manufacturing (CMC) · Supplement 15 · standardAP
1997-06-13Manufacturing (CMC) · Supplement 13 · standardAP
1997-06-13Manufacturing (CMC) · Supplement 14 · standardAP
1997-04-08Manufacturing (CMC) · Supplement 11 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 12 · standardAP
1996-10-08Manufacturing (CMC) · Supplement 8 · standardAP
1996-02-01Manufacturing (CMC) · Supplement 10 · standardAP
1995-05-08Labeling · Supplement 5 · standardAP
1994-11-21Efficacy · Supplement 1 · unknownAP
1994-11-21Efficacy · Supplement 2 · unknownAP
1993-10-26Manufacturing (CMC) · Supplement 4 · standardAP
1992-11-16Type 1 - New Molecular Entity · 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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