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FDA NDA · NDA205353

FARYDAK

Sponsor: SECURA

APPLICATION
NDA205353
TYPE
NDA
ORIGINAL APPROVAL
2015-02-23
LATEST ACTION
2016-06-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FARYDAK · ReferenceDiscontinued
PANOBINOSTAT LACTATE EQ 15MG BASE · CAPSULE · ORAL
FARYDAK · ReferenceDiscontinued
PANOBINOSTAT LACTATE EQ 20MG BASE · CAPSULE · ORAL
FARYDAK · ReferenceDiscontinued
PANOBINOSTAT LACTATE EQ 10MG BASE · CAPSULE · ORAL

Approval history

2016-06-06Labeling · Supplement 1 · standard — Letter ↗AP
2015-02-23Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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