Home Applications 205858 Application 205858
Type NDA
Sponsor GILEAD SCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZYDELIG IDELALISIB TABLET;ORAL 100MG Yes No 002 ZYDELIG IDELALISIB TABLET;ORAL 150MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N205858-001 ZYDELIG IDELALISIB 100MG TABLET / ORAL AB RLD 2014-07-23 N205858-002 ZYDELIG IDELALISIB 150MG TABLET / ORAL AB RLD, RS 2014-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 N205858-001 9492449 2030-03-11 U-1914 2016-11-16 N205858-001 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 N205858-001 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 N205858-001 9469643 2033-09-02 Drug substance 2016-11-16 N205858-002 9492449 2030-03-11 U-1914 2016-11-16 N205858-002 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 N205858-002 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 N205858-002 9469643 2033-09-02 Drug substance 2016-11-16
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 · 84 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 2026-08-18 06:07:40 2026-07 N205858-001 ZYDELIG 100MG TABLET / ORAL AB RLD 2014-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 ZYDELIG 150MG TABLET / ORAL AB RLD, RS 2014-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205858-001 ZYDELIG 100MG TABLET / ORAL RLD 2014-07-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205858-002 ZYDELIG 150MG TABLET / ORAL RLD, RS 2014-07-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 N205858-001 AB 1 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205858-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205858-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 21 · 808 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205858-001 9492449 2030-03-11 U-1914 2016-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-001 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-001 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-001 9469643 2033-09-02 Drug substance 2016-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 9492449 2030-03-11 U-1914 2016-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 9469643 2033-09-02 Drug substance 2016-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205858-001 9492449 2030-03-11 U-1914 2016-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205858-001 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205858-001 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205858-001 9469643 2033-09-02 Drug substance 2016-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205858-002 9492449 2030-03-11 U-1914 2016-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205858-002 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205858-002 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205858-002 9469643 2033-09-02 Drug substance 2016-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 8980901 2025-05-12 U-1678 2015-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 9149477 2025-05-12 U-1757 2015-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 RE44599 2025-07-21 U-1558 2014-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 RE44599 2025-07-21 U-1615 2014-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 RE44638 2025-08-05 Drug substance, Drug product 2014-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 9492449 2030-03-11 U-1914 2016-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-001 9469643 2033-09-02 Drug substance 2016-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 8980901 2025-05-12 U-1678 2015-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 9149477 2025-05-12 U-1757 2015-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 RE44599 2025-07-21 U-1615 2014-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 RE44599 2025-07-21 U-1558 2014-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 RE44638 2025-08-05 Drug substance, Drug product 2014-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 9492449 2030-03-11 U-1914 2016-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205858-002 9469643 2033-09-02 Drug substance 2016-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205858-001 8980901 2025-05-12 U-1678 2015-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205858-001 9149477 2025-05-12 U-1757 2015-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205858-001 RE44599 2025-07-21 U-1558 2014-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205858-001 RE44599 2025-07-21 U-1615 2014-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205858-001 RE44638 2025-08-05 Drug substance, Drug product 2014-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205858-001 9492449 2030-03-11 U-1914 2016-11-16 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 44 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-1701 Zydelig idelalisib Gilead Sciences, Inc. NDA Current 61958-1701 Zydelig idelalisib Gilead Sciences, Inc. NDA Current 61958-1701 Zydelig idelalisib Gilead Sciences, Inc. NDA Current 61958-1702 Zydelig idelalisib Gilead Sciences, Inc. NDA Current 61958-1702 Zydelig idelalisib Gilead Sciences, Inc. NDA Current 61958-1702 Zydelig idelalisib Gilead Sciences, Inc. NDA Current