Home Applications 210192 Application 210192
Type NDA
Sponsor VIIV HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JULUCA DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE;EQ 25MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N210192-001 JULUCA DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 N210192-001 8129385*PED 2028-04-05 Pediatric extension N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 N210192-001 9242986*PED 2030-06-08 Pediatric extension N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 N210192-001 12011506 2038-09-05 Drug product 2024-06-26
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 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210192-001 JULUCA EQ 50MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2017-11-21 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 286 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 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210192-001 8129385*PED 2028-04-05 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210192-001 9242986*PED 2030-06-08 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210192-001 8129385*PED 2028-04-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210192-001 9242986*PED 2030-06-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210192-001 8129385*PED 2028-04-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210192-001 9242986*PED 2030-06-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 8129385*PED 2028-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 9242986*PED 2030-06-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2017-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 8129385*PED 2028-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 9242986*PED 2030-06-08 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210192-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2017-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 8129385*PED 2028-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 9242986 2029-12-08 Drug substance, Drug product 2017-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 9242986*PED 2030-06-08 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 10426780 2031-01-24 U-257 Drug substance, Drug product 2019-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210192-001 12011506 2038-09-05 Drug product 2024-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2017-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210192-001 8129385 2027-10-05 Drug substance, Drug product 2017-12-20 fd3edfee7708…
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 Juluca DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE ViiV Healthcare Company 806653d1-bf35-4924-b999-ad5d21821cc1 2025-10-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 210192 application number: NDA210192 ndc (product): 49702-242
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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49702-242 Juluca dolutegravir sodium and rilpivirine hydrochloride ViiV Healthcare Company NDA Current 49702-242 Juluca dolutegravir sodium and rilpivirine hydrochloride ViiV Healthcare Company NDA Current 49702-242 Juluca dolutegravir sodium and rilpivirine hydrochloride ViiV Healthcare Company NDA Current 49702-242 Juluca dolutegravir sodium and rilpivirine hydrochloride ViiV Healthcare Company NDA Current 49702-242 Juluca dolutegravir sodium and rilpivirine hydrochloride ViiV Healthcare Company NDA Current 49702-242 Juluca dolutegravir sodium and rilpivirine hydrochloride ViiV Healthcare Company NDA Current 49702-242 Juluca dolutegravir sodium and rilpivirine hydrochloride ViiV Healthcare Company NDA Current 49702-242 Juluca dolutegravir sodium and rilpivirine hydrochloride ViiV Healthcare Company NDA Current