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 | daxibotulinumtoixnA-lanm | 0.1ML | VIAL;SINGLE-DOSE | 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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761127Orig1s000ltr.pdf |