← FDA DRUG APPROVALS

FDA NDA · NDA203388

ERIVEDGE

vismodegib

Sponsor: GENENTECH

APPLICATION
NDA203388
TYPE
NDA
ORIGINAL APPROVAL
2012-01-30
LATEST ACTION
2023-03-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ERIVEDGE · ReferencePrescription
VISMODEGIB 150MG · CAPSULE · ORAL

Approval history

2023-03-27Labeling · Supplement 17 · standard — Letter ↗AP
2020-07-31Labeling · Supplement 16 · standard — Letter ↗AP
2019-03-26Labeling · Supplement 14 · standard — Label ↗AP
2019-01-18Efficacy · Supplement 12 · standard — Label ↗AP
2017-08-01Labeling · Supplement 11 · standard — Label ↗AP
2016-11-02Labeling · Supplement 10 · standard — Letter ↗AP
2015-05-21Labeling · Supplement 6 · standard — Label ↗AP
2015-05-21Labeling · Supplement 7 · standard — Letter ↗AP
2015-05-21Labeling · Supplement 5 · standard — Letter ↗AP
2015-05-21Labeling · Supplement 8 · standard — Label ↗AP
2014-10-15Manufacturing (CMC) · Supplement 4 · priorityAP
2013-12-19Manufacturing (CMC) · Supplement 3 · priorityAP
2013-06-03Manufacturing (CMC) · Supplement 2 · priorityAP
2013-05-08Manufacturing (CMC) · Supplement 1 · priorityAP
2012-01-30Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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