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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204427
Company: ANACOR PHARMS INC

Summary Review

Products on NDA 204427

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KERYDIN	TAVABOROLE	5%	SOLUTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204427

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204427s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204427Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204427Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204427Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2018	SUPPL-6	Efficacy	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204427s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204427Orig1s006Ltr.pdf
12/14/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/26/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/27/2015	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204427s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204427Orig1s003ltr.pdf
12/15/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/20/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204427

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2018	SUPPL-6	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204427s006lbl.pdf
02/27/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204427s003lbl.pdf
02/27/2015	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204427s003lbl.pdf
07/07/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204427s000lbl.pdf

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