FDA Approval for OPZELURA issued to INCYTE CORP
$INCY
Biotechnology: Commercial Physical & Biological Resarch
Health Care
New Drug Application (NDA): 215309
Company: INCYTE CORP
Company: INCYTE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPZELURA | RUXOLITINIB | 1ML | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/21/2021 | ORIG-1 | Approval | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215309Orig1s000ltr.pdf |