Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219804
Company: ASPEN SA OPERATIONS (PTY) LTD
Company: ASPEN SA OPERATIONS (PTY) LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE | DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | 50MG/300MG/300MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/07/2026 | ORIG-1 | Tentative Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219804Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219804Orig1s000TAltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/07/2026 | ORIG-1 | Tentative Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219804Orig1s000lbl.pdf |