FDA Approval for DAXXIFY issued to REVANCE THERAPEUTICS, INC.
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Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761127
Company: REVANCE THERAPEUTICS, INC.
Company: REVANCE THERAPEUTICS, INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DAXXIFY | DAXIBOTULINUMTOXINA-LANM | 0.1ML | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/07/2022 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761127s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761127Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761127Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/11/2023 | SUPPL-2 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/07/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761127s000lbl.pdf |