← FDA DRUG APPROVALS

FDA NDA · NDA203085

STIVARGA

regorafenib

Sponsor: BAYER HLTHCARE

APPLICATION
NDA203085
TYPE
NDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2026-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

STIVARGA · ReferencePrescription
REGORAFENIB 40MG · TABLET · ORAL

Approval history

2026-02-03Labeling · Supplement 18 · standard — Letter ↗AP
2025-02-25Labeling · Supplement 16 · standard — Letter ↗AP
2020-12-10Manufacturing (CMC) · Supplement 14 · standard — Label ↗AP
2020-09-24Labeling · Supplement 12 · standard — Letter ↗AP
2020-07-21Labeling · Supplement 13 · standard — Label ↗AP
2020-02-13Labeling · Supplement 11 · standard — Label ↗AP
2019-07-31Labeling · Supplement 10 · standard — Letter ↗AP
2018-06-14Efficacy · Supplement 8 · standard — Letter ↗AP
2017-04-27Efficacy · Supplement 7 · priority — Label ↗AP
2016-08-26Labeling · Supplement 6 · standard — Letter ↗AP
2016-06-07Labeling · Supplement 5 · standard — Letter ↗AP
2015-04-13Labeling · Supplement 4 · standard — Label ↗AP
2014-11-10Manufacturing (CMC) · Supplement 2 · priorityAP
2013-09-13Manufacturing (CMC) · Supplement 3 · priorityAP
2013-05-29Labeling · Supplement 1 · standard — Label ↗AP
2012-09-27Type 1 - New Molecular Entity · Original · priority — Review ↗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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