Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204427
Company: ANACOR PHARMS INC
Company: ANACOR PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KERYDIN | TAVABOROLE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |
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 |