Home Applications 203094 Application 203094
Type NDA
Sponsor GILEAD SCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TYBOST COBICISTAT TABLET;ORAL 150MG Yes Yes 002 TYBOST COBICISTAT TABLET;ORAL 90MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203094-001 TYBOST COBICISTAT 150MG TABLET / ORAL RLD 2014-09-24 N203094-002 TYBOST COBICISTAT 90MG TABLET / ORAL RLD 2025-06-20
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 N203094-001 8148374*PED 2030-03-03 Pediatric extension N203094-001 10039718 2032-10-06 Drug product 2018-09-04 N203094-001 10039718*PED 2033-04-06 Pediatric extension N203094-002 8148374 2029-09-03 U-1279 Drug substance, Drug product 2025-07-15 N203094-002 8148374*PED 2030-03-03 Pediatric extension N203094-002 10039718 2032-10-06 Drug product 2025-07-15 N203094-002 10039718*PED 2033-04-06 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203094-001 ODE-260 2026-08-22
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 · 45 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 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 TYBOST 90MG TABLET / ORAL RLD 2025-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 TYBOST 90MG TABLET / ORAL RLD 2025-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 TYBOST 90MG TABLET / ORAL RLD 2025-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 3a93d1ddd44b…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 164 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 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-001 8148374*PED 2030-03-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-001 10039718*PED 2033-04-06 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 8148374 2029-09-03 U-1279 Drug substance, Drug product 2025-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 8148374*PED 2030-03-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 10039718 2032-10-06 Drug product 2025-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 10039718*PED 2033-04-06 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 8148374*PED 2030-03-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 10039718*PED 2033-04-06 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 8148374 2029-09-03 U-1279 Drug substance, Drug product 2025-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 8148374*PED 2030-03-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 10039718 2032-10-06 Drug product 2025-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 10039718*PED 2033-04-06 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-001 8148374*PED 2030-03-03 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-001 10039718*PED 2033-04-06 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 8148374 2029-09-03 U-1279 Drug substance, Drug product 2025-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 8148374*PED 2030-03-03 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 10039718 2032-10-06 Drug product 2025-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 10039718*PED 2033-04-06 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 8148374*PED 2030-03-03 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 10039718*PED 2033-04-06 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 8148374*PED 2030-03-03 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 10039718*PED 2033-04-06 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 8148374*PED 2030-03-03 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 10039718*PED 2033-04-06 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 8148374*PED 2030-03-03 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 10039718*PED 2033-04-06 Pediatric extension 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 55 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-1401 Tybost COBICISTAT Gilead Sciences, Inc. NDA Current 61958-1401 Tybost COBICISTAT Gilead Sciences, Inc. NDA Current 61958-1401 Tybost COBICISTAT Gilead Sciences, Inc. NDA Current 61958-1401 Tybost COBICISTAT Gilead Sciences, Inc. NDA Current 61958-1401 Tybost COBICISTAT Gilead Sciences, Inc. NDA Current 61958-1401 Tybost COBICISTAT Gilead Sciences, Inc. NDA Current 61958-1401 Tybost COBICISTAT Gilead Sciences, Inc. NDA Current