← FDA DRUG APPROVALS

FDA NDA · NDA021357

MULTIHANCE

gadobenate dimeglumine

Sponsor: BRACCO

APPLICATION
NDA021357
TYPE
NDA
ORIGINAL APPROVAL
2004-11-23
LATEST ACTION
2025-03-05
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MULTIHANCE · ReferencePrescription
GADOBENATE DIMEGLUMINE 7.935GM/15ML (529MG/ML) · INJECTABLE · INTRAVENOUS
MULTIHANCE · ReferencePrescription
GADOBENATE DIMEGLUMINE 2.645GM/5ML (529MG/ML) · INJECTABLE · INTRAVENOUS
MULTIHANCE · ReferencePrescription
GADOBENATE DIMEGLUMINE 10.58GM/20ML (529MG/ML) · INJECTABLE · INTRAVENOUS
MULTIHANCE · ReferencePrescription
GADOBENATE DIMEGLUMINE 5.29GM/10ML (529MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2025-03-05Labeling · Supplement 28 · standard — Letter ↗AP
2024-08-14Labeling · Supplement 26 · standard — Label ↗AP
2024-07-23Labeling · Supplement 27 · standard — Label ↗AP
2024-01-26Labeling · Supplement 25 · standard — Label ↗AP
2018-11-02Labeling · Supplement 18 · standard — Label ↗AP
2018-04-26Labeling · Supplement 17 · standard — Label ↗AP
2018-04-26Labeling · Supplement 16 · standard — Label ↗AP
2018-01-19Efficacy · Supplement 14 · standard — Label ↗AP
2017-09-15Labeling · Supplement 15 · standard — Label ↗AP
2013-07-30Labeling · Supplement 13 · standard — Label ↗AP
2013-01-29Manufacturing (CMC) · Supplement 12 · standardAP
2012-07-06Efficacy · Supplement 11 · standard — Letter ↗AP
2010-12-20Labeling · Supplement 9 · unknown — Letter ↗AP
2010-03-17Efficacy · Supplement 6 · standard — Letter ↗AP
2009-10-02Labeling · Supplement 4 · standard — Label ↗AP
2007-09-04Labeling · Supplement 3 · standard — Label ↗AP
2007-05-08Manufacturing (CMC) · Supplement 2AP
2004-11-23Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
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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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