Home Applications 205551 Application 205551
Type NDA
Sponsor VIIV HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIUMEQ ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;EQ 50MG BASE;300MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205551-001 TRIUMEQ ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 N205551-001 8129385*PED 2028-04-05 Pediatric extension N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 N205551-001 9242986*PED 2030-06-08 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N205551-001 M-294 2026-06-15 N205551-001 PED 2026-12-15
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205551-001 8129385*PED 2028-04-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205551-001 9242986*PED 2030-06-08 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205551-001 8129385*PED 2028-04-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205551-001 9242986*PED 2030-06-08 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205551-001 8129385*PED 2028-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205551-001 9242986*PED 2030-06-08 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 8129385*PED 2028-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 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 N205551-001 9242986*PED 2030-06-08 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205551-001 8129385*PED 2028-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205551-001 9242986*PED 2030-06-08 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 8129385*PED 2028-04-05 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 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 N205551-001 9242986*PED 2030-06-08 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 8129385*PED 2028-04-05 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 9242986*PED 2030-06-08 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 8129385*PED 2028-04-05 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 9242986*PED 2030-06-08 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 8129385*PED 2028-04-05 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 9242986*PED 2030-06-08 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 8129385*PED 2028-04-05 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 9242986*PED 2030-06-08 Pediatric extension 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205551-001 M-294 2026-06-15 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205551-001 PED 2026-12-15 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205551-001 M-294 2026-06-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205551-001 PED 2026-12-15 a50c72e98297…
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Triumeq ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE ViiV Healthcare Company 2997739a-aa91-42aa-a206-a70e2db7b84f 2024-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 205551 application number: NDA205551 ndc (product): 49702-231
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 49702-231 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine ViiV Healthcare Company NDA Current 50090-1606 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine A-S Medication Solutions NDA Current 50090-1606 Triumeq abacavir sulfate, dolutegravir sodium, lamivudine A-S Medication Solutions NDA Current