Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212527
Company: CIPLA USA INC.
Company: CIPLA USA INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE | DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE | EQ 50MG BASE; 300MG; 25MG | TABLET, FOR SUSPENSION; 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 |
|---|---|---|---|---|---|---|---|
| 03/30/2022 | ORIG-1 | Tentative Approval | Type 4 - New Combination | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212527Orig1s000TAltr.pdf |