Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210237
Company: MYLAN LABS
Company: MYLAN LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE | DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE | 50MG;200MG;25MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/09/2018 | ORIG-1 | Tentative Approval | Type 4 - New Combination | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210237Orig1s000TAltr.pdf |