Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215413
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIUMEQ PD | ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE | EQ 60MG BASE;EQ 5MG BASE;30MG | TABLET, FOR SUSPENSION;ORAL | Prescription | None | Yes | Yes |
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 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215413s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215413Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215413Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/18/2024 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205551s032,215413s003lbl.pdf | |
| 06/15/2023 | SUPPL-2 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205551s31,215413s02lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215413Orig1s002;205551Orig1s031ltr.pdf | |
| 10/07/2022 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551s029,215413s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205551Orig1s029,215413Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/18/2024 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205551s032,215413s003lbl.pdf | |
| 06/15/2023 | SUPPL-2 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205551s31,215413s02lbl.pdf | |
| 10/07/2022 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551s029,215413s001lbl.pdf | |
| 03/30/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215413s000lbl.pdf |