Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204159
Company: APOTEX
Company: APOTEX
| 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 | 180MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/05/2018 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |