Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 220379
Company: TEVA PHARMACEUTICALS INC
Company: TEVA PHARMACEUTICALS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLANZAPINE AND SAMIDORPHAN | OLANZAPINE, SAMIDORPHAN | 20MG | TABLET | None (Tentative Approval) | None | No | No |
| OLANZAPINE AND SAMIDORPHAN | OLANZAPINE, SAMIDORPHAN | 10MG | TABLET | None (Tentative Approval) | None | No | No |
| OLANZAPINE AND SAMIDORPHAN | OLANZAPINE, SAMIDORPHAN | 5MG | TABLET | None (Tentative Approval) | None | No | No |
| OLANZAPINE AND SAMIDORPHAN | OLANZAPINE, SAMIDORPHAN | 15MG | TABLET | 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 |
|---|---|---|---|---|---|---|---|
| 10/28/2026 | ORIG-1 | Tentative Approval | Labeling | UNKNOWN |
Label is not available on this site. |