← FDA DRUG APPROVALS

FDA NDA · NDA201277

GADAVIST

gadobutrol

Sponsor: BAYER HLTHCARE

APPLICATION
NDA201277
TYPE
NDA
ORIGINAL APPROVAL
2011-03-14
LATEST ACTION
2026-07-28
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

GADAVIST · ReferencePrescription
GADOBUTROL 18.1416GM/30ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADAVIST · ReferencePrescription
GADOBUTROL 6.0472GM/10ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADAVIST · ReferencePrescription
GADOBUTROL 39.3068GM/65ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADAVIST · ReferencePrescription
GADOBUTROL 9.0708GM/15ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADAVIST · ReferencePrescription
GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADAVIST · ReferencePrescription
GADOBUTROL 1.20944GM/2ML (604.72MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-07-28Labeling · Supplement 32 · standard — Label ↗AP
2026-02-13Labeling · Supplement 25 · standard — Letter ↗AP
2025-03-05Labeling · Supplement 28 · standard — Letter ↗AP
2024-07-23Labeling · Supplement 26 · standard — Label ↗AP
2024-01-26Labeling · Supplement 23 · standard — Label ↗AP
2022-04-27Labeling · Supplement 20 · standard — Label ↗AP
2020-07-30Labeling · Supplement 18 · standard — Letter ↗AP
2019-07-12Efficacy · Supplement 17 · standard — Label ↗AP
2018-11-02Labeling · Supplement 16 · standard — Label ↗AP
2018-07-26Labeling · Supplement 15 · standard — Label ↗AP
2018-04-26Labeling · Supplement 13 · standard — Label ↗AP
2016-04-27Efficacy · Supplement 11 · standard — Letter ↗AP
2015-11-25Manufacturing (CMC) · Supplement 12 · standardAP
2015-07-31Labeling · Supplement 10 · standard — Letter ↗AP
2015-06-01Manufacturing (CMC) · Supplement 9 · standardAP
2014-12-29Efficacy · Supplement 8 · priority — Label ↗AP
2014-06-11Efficacy · Supplement 7 · standard — Letter ↗AP
2013-12-18Manufacturing (CMC) · Supplement 4 · standardAP
2013-10-21Labeling · Supplement 3 · standard — Label ↗AP
2013-07-31Manufacturing (CMC) · Supplement 2 · standardAP
2012-03-22Labeling · Supplement 1 · unknown — Letter ↗AP
2011-03-14Type 1 - New Molecular Entity · Original · standard — Label ↗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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