Skip to contentApplication 213983
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIVICAY PD | DOLUTEGRAVIR | TABLET;ORAL | 5MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49702-255 | Tivicay PD | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-255 | Tivicay PD | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-255 | Tivicay PD | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-255 | Tivicay PD | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-255 | Tivicay PD | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-255 | Tivicay PD | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83991 | SUPPL | 2025-10-29 |
| 83983 | SUPPL | 2025-10-29 |
| 78171 | SUPPL | 2024-04-19 |
| 78162 | SUPPL | 2024-04-19 |
| 72299 | SUPPL | 2022-10-11 |
| 72286 | SUPPL | 2022-10-11 |
| 68063 | SUPPL | 2021-07-13 |
| 68051 | SUPPL | 2021-07-12 |
| 66864 | SUPPL | 2021-03-25 |
| 66856 | SUPPL | 2021-03-24 |
| 65174 | ORIG | 2020-11-09 |
| 63574 | ORIG | 2020-06-16 |
| 63566 | ORIG | 2020-06-15 |