Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215448
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE | DOLUTEGRAVIR, EMTRICITABINE and 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 |
---|---|---|---|---|---|---|---|
05/26/2023 | ORIG-1 | Tentative Approval | Type 4 - New Combination | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215448Orig1s000TAltr.pdf |