Application 215413
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIUMEQ PD | ABACAVIR DOLUTEGRAVIR LAMIVUDINE | TABLET, FOR SUSPENSION; ORAL | EQ 60MG BASE; 5MG; 30MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49702-258 | Triumeq PD | abacavir sulfate, dolutegravir sodium, lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-258 | Triumeq PD | abacavir sulfate, dolutegravir sodium, lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-258 | Triumeq PD | abacavir sulfate, dolutegravir sodium, lamivudine | ViiV Healthcare Company | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83985 | SUPPL | 2025-10-29 |
| 83969 | SUPPL | 2025-10-29 |
| 83968 | SUPPL | 2025-10-29 |
| 78165 | SUPPL | 2024-04-19 |
| 74521 | SUPPL | 2023-06-16 |
| 74508 | SUPPL | 2023-06-16 |
| 72303 | SUPPL | 2022-10-11 |
| 72302 | SUPPL | 2022-10-11 |
| 72288 | SUPPL | 2022-10-11 |
| 71048 | ORIG | 2022-05-12 |
| 70676 | ORIG | 2022-03-31 |
| 70675 | ORIG | 2022-03-31 |
| 70670 | ORIG | 2022-03-31 |