Application 204790
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIVICAY | DOLUTEGRAVIR SODIUM | TABLET;ORAL | EQ 50MG BASE | Yes | Yes |
| 002 | TIVICAY | DOLUTEGRAVIR SODIUM | TABLET;ORAL | EQ 10MG BASE | Yes | No |
| 003 | TIVICAY | DOLUTEGRAVIR SODIUM | TABLET;ORAL | EQ 25MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204790-001 | TIVICAY | DOLUTEGRAVIR SODIUM | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | |
| N204790-002 | TIVICAY | DOLUTEGRAVIR SODIUM | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | |
| N204790-003 | TIVICAY | DOLUTEGRAVIR SODIUM | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | |
| N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | ||
| N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | |
| N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | ||
| N204790-002 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | |
| N204790-002 | 8129385*PED | 2028-04-05 | Pediatric extension | ||
| N204790-002 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | |
| N204790-002 | 9242986*PED | 2030-06-08 | Pediatric extension | ||
| N204790-003 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | |
| N204790-003 | 8129385*PED | 2028-04-05 | Pediatric extension | ||
| N204790-003 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | |
| N204790-003 | 9242986*PED | 2030-06-08 | Pediatric extension |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | 8129385*PED | 2028-04-05 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | 9242986*PED | 2030-06-08 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | 8129385*PED | 2028-04-05 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | 9242986*PED | 2030-06-08 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | 8129385*PED | 2028-04-05 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | 9242986*PED | 2030-06-08 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | 8129385*PED | 2028-04-05 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | 9242986*PED | 2030-06-08 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | 8129385*PED | 2028-04-05 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | 9242986*PED | 2030-06-08 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | 8129385*PED | 2028-04-05 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | 9242986*PED | 2030-06-08 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | fd3edfee7708… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N204790-001 | I-758 | 2020-11-21 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N204790-002 | I-758 | 2020-11-21 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N204790-003 | I-758 | 2020-11-21 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N204790-001 | I-758 | 2020-11-21 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N204790-002 | I-758 | 2020-11-21 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N204790-003 | I-758 | 2020-11-21 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N204790-001 | I-758 | 2020-11-21 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N204790-002 | I-758 | 2020-11-21 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N204790-003 | I-758 | 2020-11-21 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N204790-001 | I-758 | 2020-11-21 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N204790-002 | I-758 | 2020-11-21 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N204790-003 | I-758 | 2020-11-21 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N204790-001 | I-758 | 2020-11-21 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N204790-002 | I-758 | 2020-11-21 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N204790-003 | I-758 | 2020-11-21 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N204790-001 | I-758 | 2020-11-21 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N204790-002 | I-758 | 2020-11-21 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N204790-003 | I-758 | 2020-11-21 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tivicay | DOLUTEGRAVIR SODIUM | ST. MARY'S MEDICAL PARK PHARMACY | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2026-05-22 | Warnings, Adverse reactions | 204790 NDA204790 |
| Tivicay | DOLUTEGRAVIR SODIUM | ViiV Healthcare Company | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 2025-10-29 | Warnings, Adverse reactions | 204790 NDA204790 49702-226 49702-227 49702-228 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-226 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-227 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 49702-228 | Tivicay | dolutegravir sodium | ViiV Healthcare Company | NDA | Current |
| 50090-1355 | Tivicay | dolutegravir sodium | A-S Medication Solutions | NDA | Current |
| 53808-1130 | Tivicay | dolutegravir sodium | DOH CENTRAL PHARMACY | NDA | Current |
| 67296-1818 | Tivicay | dolutegravir sodium | RedPharm Drug, Inc. | NDA | Current |
| 70518-1487 | Tivicay | dolutegravir sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1487 | Tivicay | dolutegravir sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1487 | Tivicay | dolutegravir sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1487 | Tivicay | dolutegravir sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1487 | Tivicay | dolutegravir sodium | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83982 | SUPPL | 2025-10-29 |
| 83975 | SUPPL | 2025-10-29 |
| 78170 | SUPPL | 2024-04-19 |
| 78161 | SUPPL | 2024-04-19 |
| 72298 | SUPPL | 2022-10-11 |
| 72285 | SUPPL | 2022-10-11 |
| 68062 | SUPPL | 2021-07-13 |
| 68050 | SUPPL | 2021-07-12 |
| 66863 | SUPPL | 2021-03-25 |
| 66855 | SUPPL | 2021-03-24 |
| 63573 | SUPPL | 2020-06-16 |
| 63565 | SUPPL | 2020-06-15 |
| 62331 | SUPPL | 2020-03-25 |
| 62325 | SUPPL | 2020-03-25 |
| 60691 | SUPPL | 2019-10-28 |
| 60668 | SUPPL | 2019-10-25 |
| 55444 | SUPPL | 2018-09-12 |
| 55443 | SUPPL | 2018-09-12 |
| 55417 | SUPPL | 2018-09-10 |
| 55416 | SUPPL | 2018-09-10 |
| 50499 | SUPPL | 2017-11-27 |
| 50480 | SUPPL | 2017-11-24 |
| 47763 | SUPPL | 2017-03-29 |
| 47734 | SUPPL | 2017-03-28 |
| 32593 | SUPPL | 2016-06-10 |
| 19602 | SUPPL | 2016-06-10 |
| 40423 | SUPPL | 2016-04-29 |
| 32592 | SUPPL | 2016-04-26 |
| 10396 | SUPPL | 2015-08-10 |
| 19601 | SUPPL | 2015-08-07 |
| 19600 | SUPPL | 2015-01-08 |
| 32591 | SUPPL | 2014-12-24 |
| 40422 | SUPPL | 2014-05-13 |
| 32590 | SUPPL | 2014-05-13 |
| 43479 | ORIG | 2013-09-13 |
| 24481 | ORIG | 2013-09-13 |
| 10395 | ORIG | 2013-08-20 |
| 19599 | ORIG | 2013-08-19 |
| 54054 | SUPPL | 1900-01-01 |
| 52619 | SUPPL | 1900-01-01 |
| 52618 | SUPPL | 1900-01-01 |
| 52616 | ORIG | 1900-01-01 |
| 52615 | ORIG | 1900-01-01 |
| 52614 | ORIG | 1900-01-01 |