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 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 N205858-001 ZYDELIG 100MG TABLET / ORAL AB RLD 2014-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 ZYDELIG 150MG TABLET / ORAL AB RLD, RS 2014-07-23 84e616aacf4f…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 21 · 816 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N205858-001 9492449 2030-03-11 U-1914 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-001 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-001 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-001 9469643 2033-09-02 Drug substance 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 9492449 2030-03-11 U-1914 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 9469643 2033-09-02 Drug substance 2016-11-16 84e616aacf4f…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 44 observed states.
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 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