Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203959
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/18/2017 | ORIG-1 | Approval |
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