Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204866
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 06/16/2017 | ORIG-1 | Approval | STANDARD |
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