Application 213983
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIVICAY PD | DOLUTEGRAVIR | TABLET;ORAL | 5MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N213983-001 | TIVICAY PD | DOLUTEGRAVIR SODIUM | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | |
| N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | ||
| N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | |
| N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N213983-001 | NPP | 2029-08-25 |
| N213983-001 | PED | 2030-02-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N213983-001 | TIVICAY PD | EQ 5MG BASE | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2020-06-12 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213983-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2020-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213983-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213983-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2020-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213983-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 2680178bc6a6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N213983-001 | NPP | 2029-08-25 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N213983-001 | PED | 2030-02-25 | c2088c7a36db… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |
|---|---|---|
| 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 |