Home Applications 204790 Application 204790
Type NDA
Sponsor VIIV HLTHCARE Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table 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TIVICAY DOLUTEGRAVIR SODIUM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09 N204790-003 TIVICAY DOLUTEGRAVIR SODIUM EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-06-09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# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table 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.
Product history page 2 of 4 · 132 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 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…2024-05-31 18:47 UTC 2024-05 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N204790-003 TIVICAY EQ 25MG BASE TABLET / ORAL RLD 2016-06-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204790-001 TIVICAY EQ 50MG BASE TABLET / ORAL RLD, RS 2013-08-12 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N204790-002 TIVICAY EQ 10MG BASE TABLET / ORAL RLD 2016-06-09 c0c555d07b60…
Observed Orange Book patent history# Patent history page 1 of 11 · 402 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-001 8129385*PED 2028-04-05 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-001 9242986*PED 2030-06-08 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-002 8129385*PED 2028-04-05 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-002 9242986*PED 2030-06-08 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-003 8129385*PED 2028-04-05 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204790-003 9242986*PED 2030-06-08 Pediatric extension c2088c7a36db…2026-09-14 22:38:34 2026-08 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-001 8129385*PED 2028-04-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-001 9242986*PED 2030-06-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-002 8129385*PED 2028-04-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-002 9242986*PED 2030-06-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-003 8129385*PED 2028-04-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204790-003 9242986*PED 2030-06-08 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204790-001 8129385 2027-10-05 Drug substance, Drug product 2013-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-001 8129385*PED 2028-04-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-001 9242986*PED 2030-06-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-002 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-002 8129385*PED 2028-04-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-002 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-002 9242986*PED 2030-06-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-003 8129385 2027-10-05 Drug substance, Drug product 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-003 8129385*PED 2028-04-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-003 9242986 2029-12-08 Drug substance, Drug product 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204790-003 9242986*PED 2030-06-08 Pediatric extension caaa826d4ba7…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…
Observed Orange Book exclusivity history# 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 Tivicay DOLUTEGRAVIR SODIUM ST. MARY'S MEDICAL PARK PHARMACY 485bc9db-8665-9f5a-e063-6394a90a7921 2026-05-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 204790 application number: NDA204790
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 · 38 matching rows.
NDC, Name, Nonproprietary name table 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