Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 204427
Company: ANACOR PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KERYDIN TAVABOROLE 5% SOLUTION;TOPICAL Prescription AB Yes Yes
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.

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

KERYDIN

SOLUTION;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KERYDIN TAVABOROLE 5% SOLUTION;TOPICAL Prescription Yes AB 204427 ANACOR PHARMS INC
TAVABOROLE TAVABOROLE 5% SOLUTION;TOPICAL Prescription No AB 212188 ALEOR DERMACEUTICALS
TAVABOROLE TAVABOROLE 5% SOLUTION;TOPICAL Prescription No AB 212256 AMNEAL
TAVABOROLE TAVABOROLE 5% SOLUTION;TOPICAL Prescription No AB 212224 CIPLA
TAVABOROLE TAVABOROLE 5% SOLUTION;TOPICAL Prescription No AB 211297 ENCUBE
TAVABOROLE TAVABOROLE 5% SOLUTION;TOPICAL Prescription No AB 212168 LUPIN LTD
TAVABOROLE TAVABOROLE 5% SOLUTION;TOPICAL Prescription No AB 211848 PADAGIS US
TAVABOROLE TAVABOROLE 5% SOLUTION;TOPICAL Prescription No AB 212215 TARO PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English