Home Applications 210455 Application 210455
Type NDA
Sponsor JANSSEN PRODS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYMTUZA COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE TABLET;ORAL 150MG;800MG;200MG;EQ 10MG 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 N210455-001 SYMTUZA COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2353 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2364 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2365 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2766 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2767 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2768 Drug substance, Drug product 2018-08-15 N210455-001 8754065 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 N210455-001 8754065 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 N210455-001 9296769 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 N210455-001 9296769 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 N210455-001 10039718 2032-10-06 Drug product 2018-09-05 N210455-001 10786518 2038-07-19 U-2978 2020-10-28
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 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 18 · 683 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 N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 8148374 2029-09-03 U-2353 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 8148374 2029-09-03 U-2767 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 8148374 2029-09-03 U-2768 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 8148374 2029-09-03 U-2766 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 8148374 2029-09-03 U-2364 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 8148374 2029-09-03 U-2365 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 8754065 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 8754065 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 9296769 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 9296769 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 10039718 2032-10-06 Drug product 2018-09-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210455-001 10786518 2038-07-19 U-2978 2020-10-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 8148374 2029-09-03 U-2353 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 8148374 2029-09-03 U-2767 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 8148374 2029-09-03 U-2768 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 8148374 2029-09-03 U-2766 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 8148374 2029-09-03 U-2364 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 8148374 2029-09-03 U-2365 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 8754065 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 8754065 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 9296769 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 9296769 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 10039718 2032-10-06 Drug product 2018-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210455-001 10786518 2038-07-19 U-2978 2020-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 8148374 2029-09-03 U-2353 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 8148374 2029-09-03 U-2767 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 8148374 2029-09-03 U-2768 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 8148374 2029-09-03 U-2766 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 8148374 2029-09-03 U-2364 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 8148374 2029-09-03 U-2365 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 8754065 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 8754065 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 9296769 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 9296769 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 10039718 2032-10-06 Drug product 2018-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210455-001 10786518 2038-07-19 U-2978 2020-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 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 Symtuza DARUNAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE Janssen Products LP 85a17d00-6b7c-41ea-a6b3-5ad924820dab 2026-04-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 210455 application number: NDA210455 ndc (product): 59676-800
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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current 59676-800 Symtuza Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide Janssen Products LP NDA Current