Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 205353
Company: SECURA

• Medication Guide

• REMS

• Summary Review

Products on NDA 205353

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FARYDAK	PANOBINOSTAT LACTATE	EQ 10MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No
FARYDAK	PANOBINOSTAT LACTATE	EQ 15MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No
FARYDAK	PANOBINOSTAT LACTATE	EQ 20MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205353

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205353Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205353Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205353Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2016	SUPPL-1	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205353Orig1s001ltr.pdf

Labels for NDA 205353

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf