FDA Approval for OPVEE (nalmefene) issued to OPIANT PHARMACEUTICALS INC
Company: OPIANT PHARMACEUTICALS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OPVEE (nalmefene) | 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 | STANDARD |
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