Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211148
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | 10MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | 15MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | 25MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | 120MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | 200MG | TABLET; ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/02/2024 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |