Application 205858

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYDELIGIDELALISIBTABLET;ORAL100MGYesNo
002ZYDELIGIDELALISIBTABLET;ORAL150MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205858-001ZYDELIGIDELALISIB100MGTABLET / ORALABRLD2014-07-23
N205858-002ZYDELIGIDELALISIB150MGTABLET / ORALABRLD, RS2014-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N205858-001AB
N205858-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205858-00194924492030-03-11U-19142016-11-16
N205858-001107308792033-03-05Drug substance, Drug product2020-09-03
N205858-00188657302033-03-05U-1615Drug substance, Drug product2014-11-18
N205858-00194696432033-09-02Drug substance2016-11-16
N205858-00294924492030-03-11U-19142016-11-16
N205858-002107308792033-03-05Drug substance, Drug product2020-09-03
N205858-00288657302033-03-05U-1615Drug substance, Drug product2014-11-18
N205858-00294696432033-09-02Drug substance2016-11-16

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N205858-001ZYDELIG100MGTABLET / ORALABRLD2014-07-2384e616aacf4f…
2026-09-14 22:38:342026-08N205858-002ZYDELIG150MGTABLET / ORALABRLD, RS2014-07-2384e616aacf4f…
2026-08-18 06:07:402026-07N205858-001ZYDELIG100MGTABLET / ORALABRLD2014-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-002ZYDELIG150MGTABLET / ORALABRLD, RS2014-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205858-001ZYDELIG100MGTABLET / ORALRLD2014-07-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205858-002ZYDELIG150MGTABLET / ORALRLD, RS2014-07-2374a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N205858-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N205858-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N205858-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205858-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205858-002AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 21 · 816 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N205858-00194924492030-03-11U-19142016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N205858-001107308792033-03-05Drug substance, Drug product2020-09-0384e616aacf4f…
2026-09-14 22:38:342026-08N205858-00188657302033-03-05U-1615Drug substance, Drug product2014-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N205858-00194696432033-09-02Drug substance2016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N205858-00294924492030-03-11U-19142016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N205858-002107308792033-03-05Drug substance, Drug product2020-09-0384e616aacf4f…
2026-09-14 22:38:342026-08N205858-00288657302033-03-05U-1615Drug substance, Drug product2014-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N205858-00294696432033-09-02Drug substance2016-11-1684e616aacf4f…
2026-08-18 06:07:402026-07N205858-00194924492030-03-11U-19142016-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-001107308792033-03-05Drug substance, Drug product2020-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-00188657302033-03-05U-1615Drug substance, Drug product2014-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-00194696432033-09-02Drug substance2016-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-00294924492030-03-11U-19142016-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-002107308792033-03-05Drug substance, Drug product2020-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-00288657302033-03-05U-1615Drug substance, Drug product2014-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N205858-00294696432033-09-02Drug substance2016-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205858-00194924492030-03-11U-19142016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205858-001107308792033-03-05Drug substance, Drug product2020-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205858-00188657302033-03-05U-1615Drug substance, Drug product2014-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205858-00194696432033-09-02Drug substance2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205858-00294924492030-03-11U-19142016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205858-002107308792033-03-05Drug substance, Drug product2020-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205858-00288657302033-03-05U-1615Drug substance, Drug product2014-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205858-00294696432033-09-02Drug substance2016-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-00189809012025-05-12U-16782015-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-00191494772025-05-12U-17572015-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-001RE445992025-07-21U-15582014-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-001RE445992025-07-21U-16152014-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-001RE446382025-08-05Drug substance, Drug product2014-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-00194924492030-03-11U-19142016-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-001107308792033-03-05Drug substance, Drug product2020-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-00188657302033-03-05U-1615Drug substance, Drug product2014-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-00194696432033-09-02Drug substance2016-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-00289809012025-05-12U-16782015-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-00291494772025-05-12U-17572015-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-002RE445992025-07-21U-16152014-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-002RE445992025-07-21U-15582014-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-002RE446382025-08-05Drug substance, Drug product2014-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-00294924492030-03-11U-19142016-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205858-002107308792033-03-05Drug substance, Drug product2020-09-0331067a03dcf5…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N205858-001NCE2019-07-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205858-001ODE-702021-07-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205858-001ODE-712021-07-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205858-002NCE2019-07-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205858-002ODE-702021-07-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205858-002ODE-712021-07-2374a2ff9319b5…
2021-12-28 21:50 UTC2021-12N205858-001ODE-702021-07-23782e0a99824c…
2021-12-28 21:50 UTC2021-12N205858-001ODE-712021-07-23782e0a99824c…
2021-12-28 21:50 UTC2021-12N205858-002ODE-702021-07-23782e0a99824c…
2021-12-28 21:50 UTC2021-12N205858-002ODE-712021-07-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205858-001ODE-702021-07-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205858-001ODE-712021-07-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205858-002ODE-702021-07-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205858-002ODE-712021-07-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N205858-001ODE-702021-07-235aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N205858-001ODE-712021-07-235aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N205858-002ODE-702021-07-235aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N205858-002ODE-712021-07-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205858-001ODE-702021-07-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205858-001ODE-712021-07-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205858-002ODE-702021-07-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205858-002ODE-712021-07-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205858-001ODE-702021-07-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205858-001ODE-712021-07-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205858-002ODE-702021-07-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205858-002ODE-712021-07-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205858-001NCE2019-07-233f01610625f2…
2019-12-14 00:12 UTC2019-12N205858-001ODE-702021-07-233f01610625f2…
2019-12-14 00:12 UTC2019-12N205858-001ODE-712021-07-233f01610625f2…
2019-12-14 00:12 UTC2019-12N205858-002NCE2019-07-233f01610625f2…
2019-12-14 00:12 UTC2019-12N205858-002ODE-702021-07-233f01610625f2…
2019-12-14 00:12 UTC2019-12N205858-002ODE-712021-07-233f01610625f2…
2019-09-15 20:21 UTC2019-09N205858-001NCE2019-07-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N205858-001ODE-702021-07-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N205858-001ODE-712021-07-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N205858-002NCE2019-07-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N205858-002ODE-702021-07-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N205858-002ODE-712021-07-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N205858-001NCE2019-07-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N205858-001ODE-702021-07-23ea99ee380514…

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-1701ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1701ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1701ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1702ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1702ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1702ZydeligidelalisibGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71527SUPPL2022-07-07
70483SUPPL2022-03-11
70210SUPPL2022-02-22
70198SUPPL2022-02-22
70197SUPPL2022-02-22
64963SUPPL2020-10-21
64955SUPPL2020-10-21
64954SUPPL2020-10-21
57113SUPPL2019-01-30
55897SUPPL2018-10-11
53502SUPPL2018-03-28
52518SUPPL2018-02-08
52509SUPPL2018-02-08
52400SUPPL2018-02-05
52399SUPPL2018-02-05
52127SUPPL2018-01-30
52083SUPPL2018-01-30
50567SUPPL2017-12-01
50529SUPPL2017-11-30
46678SUPPL2017-01-05
45411SUPPL2016-09-29
45362SUPPL2016-09-22
44935ORIG2015-02-06
23007ORIG2015-02-06
44599ORIG2014-08-01
10520ORIG2014-07-24
40518ORIG2014-07-23