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FDA NDA · NDA202429

ZELBORAF

vemurafenib

Sponsor: HOFFMANN LA ROCHE

APPLICATION
NDA202429
TYPE
NDA
ORIGINAL APPROVAL
2011-08-17
LATEST ACTION
2020-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZELBORAF · ReferencePrescription
VEMURAFENIB 240MG · TABLET · ORAL

Approval history

2020-05-18Labeling · Supplement 19 · standard — Letter ↗AP
2017-11-06Efficacy · Supplement 16 · priority — Label ↗AP
2017-09-13Efficacy · Supplement 14 · standard — Letter ↗AP
2017-09-13Labeling · Supplement 15 · standard — Letter ↗AP
2017-04-17Labeling · Supplement 12 · standard — Letter ↗AP
2016-08-31Efficacy · Supplement 9 · standard — Label ↗AP
2016-05-09Labeling · Supplement 10 · standard — Letter ↗AP
2015-08-11Labeling · Supplement 8 · standard — Label ↗AP
2014-11-25Labeling · Supplement 6 · standard — Label ↗AP
2014-09-23Manufacturing (CMC) · Supplement 7 · priorityAP
2014-03-19Efficacy · Supplement 4 · standard — Label ↗AP
2014-02-06Labeling · Supplement 5 · standard — Letter ↗AP
2013-07-03Labeling · Supplement 3 · standard — Label ↗AP
2013-07-03Labeling · Supplement 2 · standard — Label ↗AP
2011-08-17Type 1 - New Molecular Entity · Original · priority — 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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