Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213189
Company: ALMIRALL
Company: ALMIRALL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KLISYRI | TIRBANIBULIN | 1% | OINTMENT;TOPICAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
12/14/2020 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213189s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213189Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213189Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/07/2024 | SUPPL-5 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213189s001s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213189Orig1s001,s003,s005ltr.pdf | |
06/07/2024 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213189s001s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213189Orig1s001,s003,s005ltr.pdf | |
06/07/2024 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213189s001s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213189Orig1s001,s003,s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/07/2024 | SUPPL-5 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213189s001s003s005lbl.pdf | |
06/07/2024 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213189s001s003s005lbl.pdf | |
06/07/2024 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213189s001s003s005lbl.pdf | |
12/14/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213189s000lbl.pdf |