← FDA DRUG APPROVALS

FDA NDA · NDA021358

MULTIHANCE

gadobenate dimeglumine

Sponsor: BRACCO

APPLICATION
NDA021358
TYPE
NDA
ORIGINAL APPROVAL
2004-11-23
LATEST ACTION
2025-03-05
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MULTIHANCE MULTIPACK · ReferencePrescription
GADOBENATE DIMEGLUMINE 52.9GM/100ML (529MG/ML) · INJECTABLE · INTRAVENOUS
MULTIHANCE MULTIPACK · ReferencePrescription
GADOBENATE DIMEGLUMINE 26.45GM/50ML (529MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2025-03-05Labeling · Supplement 26 · standard — Letter ↗AP
2024-08-14Labeling · Supplement 24 · standard — Label ↗AP
2024-07-23Labeling · Supplement 25 · standard — Label ↗AP
2024-01-26Labeling · Supplement 23 · standard — Label ↗AP
2018-11-02Labeling · Supplement 17 · standard — Label ↗AP
2018-04-26Labeling · Supplement 16 · standard — Label ↗AP
2018-04-26Labeling · Supplement 15 · standard — Label ↗AP
2018-01-19Efficacy · Supplement 13 · standard — Label ↗AP
2017-09-15Labeling · Supplement 14 · standard — Label ↗AP
2013-07-30Labeling · Supplement 12 · standard — Label ↗AP
2013-01-29Manufacturing (CMC) · Supplement 11 · standardAP
2012-07-06Efficacy · Supplement 9 · standard — Label ↗AP
2011-09-29Labeling · Supplement 10 · unknown — Letter ↗AP
2011-02-16Labeling · Supplement 8 · unknown — Letter ↗AP
2007-09-04Labeling · Supplement 3 · standard — Letter ↗AP
2007-05-08Manufacturing (CMC) · Supplement 2AP
2004-11-23Type 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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