Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209601
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Discontinued | None | No | No |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/29/2025 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2020 | 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. |