New Drug Application (NDA): 204803
Company: DURECT CORP
Company: DURECT CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POSIMIR | BUPIVACAINE | 132MG/ML | INJECTABLE;INJECTION | Prescription | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 02/01/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
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