Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216674
Company: ACCORD HLTHCARE INC
Company: ACCORD HLTHCARE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 234MG | INJECTABLE; SUSPENSION, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 156MG | INJECTABLE; SUSPENSION, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 117MG | INJECTABLE; SUSPENSION, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 78MG | INJECTABLE; SUSPENSION, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 39MG | INJECTABLE; SUSPENSION, EXTENDED RELEASE | 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 |
|---|---|---|---|---|---|---|---|
| 05/16/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |