← FDA DRUG APPROVALS

FDA NDA · NDA022090

EOVIST

gadoxetate disodium

Sponsor: BAYER HLTHCARE

APPLICATION
NDA022090
TYPE
NDA
ORIGINAL APPROVAL
2008-07-03
LATEST ACTION
2026-02-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EOVIST · ReferencePrescription
GADOXETATE DISODIUM 2.72145GM/15ML (181.43MG/ML) · SOLUTION · INTRAVENOUS
EOVIST · ReferencePrescription
GADOXETATE DISODIUM 1.8143GM/10ML (181.43MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-02-13Labeling · Supplement 25 · standard — Letter ↗AP
2025-03-05Labeling · Supplement 27 · standard — Letter ↗AP
2024-08-14Labeling · Supplement 23 · standard — Letter ↗AP
2024-07-23Labeling · Supplement 26 · standard — Label ↗AP
2024-01-30Labeling · Supplement 24 · standard — Label ↗AP
2021-12-28Labeling · Supplement 20 · standard — Label ↗AP
2021-12-01Labeling · Supplement 19 · standard — Label ↗AP
2018-11-02Labeling · Supplement 16 · standard — Label ↗AP
2018-07-26Labeling · Supplement 15 · standard — Label ↗AP
2018-04-26Labeling · Supplement 14 · standard — Label ↗AP
2015-10-26Manufacturing (CMC) · Supplement 12 · standardAP
2015-03-27Efficacy · Supplement 11 · standard — Label ↗AP
2014-01-16Manufacturing (CMC) · Supplement 10 · standardAP
2013-10-16Labeling · Supplement 8 · standard — Letter ↗AP
2013-02-04Manufacturing (CMC) · Supplement 3 · standardAP
2011-11-16Labeling · Supplement 5 · unknown — Letter ↗AP
2010-12-20Labeling · Supplement 4 · unknown — Label ↗AP
2009-11-13Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2008-07-03Type 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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