FDA Approval for PEDMARK issued to FENNEC PHARMACEUTICALS INC
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Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 212937
Company: FENNEC PHARMACEUTICALS INC
Company: FENNEC PHARMACEUTICALS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEDMARK | SODIUM THIOSULFATE | 12.5G;100ML | INJECTABLE;INJECTION | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 09/20/2022 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
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