Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217889
Company: QILU
Company: QILU
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 117MG/0.75ML | SUSPENSION, EXTENDED RELEASE;INJECTABLE | None (Tentative Approval) | None | No | No |
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 156MG/ML | SUSPENSION, EXTENDED RELEASE;INJECTABLE | None (Tentative Approval) | None | No | No |
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 234MG/1.5ML | SUSPENSION, EXTENDED RELEASE;INJECTABLE | 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 |
|---|---|---|---|---|---|---|---|
| 06/28/2024 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |