FDA Approval for OPVEE issued to OPIANT PHARMACEUTICALS INC
$OPNT
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 217470
Company: OPIANT PHARMACEUTICALS INC
Company: OPIANT PHARMACEUTICALS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPVEE | NALMEFENE | 2.7MG | SPRAY;NASAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/22/2023 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217470Orig1s000.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217470Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/22/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217470Orig1s000.pdf |