Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216228
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 273MG/0.88ML | SUSPENSION, EXTENDED RELEASE;INJECTABLE | None (Tentative Approval) | None | No | No |
| PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | 410MG/1.32ML | 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 |
|---|---|---|---|---|---|---|---|
| 05/20/2024 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |