← FDA DRUG APPROVALS

FDA NDA · NDA021991

ZOLINZA

vorinostat

Sponsor: MSD SUB MERCK

APPLICATION
NDA021991
TYPE
NDA
ORIGINAL APPROVAL
2006-10-06
LATEST ACTION
2018-12-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ZOLINZA · ReferencePrescription
VORINOSTAT 100MG · CAPSULE · ORAL

Approval history

2018-12-11Labeling · Supplement 9 · standard — Label ↗AP
2015-12-17Labeling · Supplement 8 · standard — Letter ↗AP
2015-10-07Manufacturing (CMC) · Supplement 7 · priorityAP
2013-04-24Labeling · Supplement 6 · standardAP
2011-11-14Labeling · Supplement 2 · standard — Label ↗AP
2011-06-10Labeling · Supplement 5 · unknown — Letter ↗AP
2009-09-23Efficacy · Supplement 4 · standard — Letter ↗AP
2008-07-22Labeling · Supplement 1 · standard — Letter ↗AP
2006-10-06Type 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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