Home Applications 203100 Application 203100
Type NDA
Sponsor GILEAD SCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STRIBILD COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 150MG;150MG;200MG;300MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N203100-001 STRIBILD COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203100-001 7176220 2026-08-27 U-257 Drug substance, Drug product N203100-001 7635704 2026-10-26 U-257 Drug substance, Drug product N203100-001 8981103 2026-10-26 Drug substance, Drug product 2015-04-14 N203100-001 7176220*PED 2027-02-27 Pediatric extension N203100-001 7635704*PED 2027-04-26 Pediatric extension N203100-001 8981103*PED 2027-04-26 Pediatric extension N203100-001 8148374 2029-09-03 U-1279 Drug substance, Drug product N203100-001 9891239 2029-09-03 U-257 Drug product 2018-03-06 N203100-001 8148374*PED 2030-03-03 Pediatric extension N203100-001 9891239*PED 2030-03-03 Pediatric extension N203100-001 8633219 2030-04-30 U-257 Drug product 2014-01-24 N203100-001 8633219*PED 2030-10-30 Pediatric extension N203100-001 10039718 2032-10-06 Drug product 2018-09-04 N203100-001 10039718*PED 2033-04-06 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 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203100-001 STRIBILD 150MG;150MG;200MG;300MG TABLET / ORAL RLD, RS 2012-08-27 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 18 · 691 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203100-001 7176220 2026-08-27 U-257 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 7635704 2026-10-26 U-257 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 8981103 2026-10-26 Drug substance, Drug product 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 7176220*PED 2027-02-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 7635704*PED 2027-04-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 8981103*PED 2027-04-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 9891239 2029-09-03 U-257 Drug product 2018-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 8148374*PED 2030-03-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 9891239*PED 2030-03-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 8633219 2030-04-30 U-257 Drug product 2014-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 8633219*PED 2030-10-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 10039718 2032-10-06 Drug product 2018-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203100-001 10039718*PED 2033-04-06 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 7176220 2026-08-27 U-257 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 7635704 2026-10-26 U-257 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 8981103 2026-10-26 Drug substance, Drug product 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 7176220*PED 2027-02-27 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 7635704*PED 2027-04-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 8981103*PED 2027-04-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 9891239 2029-09-03 U-257 Drug product 2018-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 8148374*PED 2030-03-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 9891239*PED 2030-03-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 8633219 2030-04-30 U-257 Drug product 2014-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 8633219*PED 2030-10-30 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 10039718 2032-10-06 Drug product 2018-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203100-001 10039718*PED 2033-04-06 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203100-001 7176220 2026-08-27 U-257 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 7635704 2026-10-26 U-257 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 8981103 2026-10-26 Drug substance, Drug product 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 7176220*PED 2027-02-27 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 7635704*PED 2027-04-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 8981103*PED 2027-04-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 9891239 2029-09-03 U-257 Drug product 2018-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 8148374*PED 2030-03-03 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 9891239*PED 2030-03-03 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 8633219 2030-04-30 U-257 Drug product 2014-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203100-001 8633219*PED 2030-10-30 Pediatric extension 6a471c1ec25d…
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 Stribild ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE Gilead Sciences, Inc. 74ae2a93-b267-444c-8f0f-a2a6522260ee 2025-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203100 application number: NDA203100 ndc (product): 61958-1201
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 50090-1318 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate A-S Medication Solutions NDA Current 50090-1318 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate A-S Medication Solutions NDA Current 53808-0887 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate State of Florida DOH Central Pharmacy NDA Current 61958-1201 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 61958-1201 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 61958-1201 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 61958-1201 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 61958-1201 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 69189-1201 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate Avera McKennan Hospital NDA Current 70518-0674 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate REMEDYREPACK INC. NDA Current 70518-0674 Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate REMEDYREPACK INC. NDA Current