Home Applications 217003 Application 217003
Type NDA
Sponsor PHARMACYCLICS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMBRUVICA IBRUTINIB SUSPENSION;ORAL 70MG/ML No No 002 IMBRUVICA IBRUTINIB CAPSULE;ORAL 70MG No No 003 IMBRUVICA IBRUTINIB CAPSULE;ORAL 140MG No No 004 IMBRUVICA IBRUTINIB TABLET;ORAL 140MG No No 005 IMBRUVICA IBRUTINIB TABLET;ORAL 230MG No No 006 IMBRUVICA IBRUTINIB TABLET;ORAL 420MG No No 007 IMBRUVICA IBRUTINIB TABLET;ORAL 560MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N217003-001 IMBRUVICA IBRUTINIB 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24
Orange Book patents# Current patent rows page 1 of 2 · 86 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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.
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 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 41 · 1,639 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 N217003-001 7514444 2026-12-28 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8476284 2026-12-28 U-3843 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8476284 2026-12-28 U-3844 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8476284 2026-12-28 U-3845 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3422 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3842 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3843 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3845 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3844 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-2666 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-2970 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8697711 2026-12-28 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8703780 2026-12-28 U-2666 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8703780 2026-12-28 U-3842 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8735403 2026-12-28 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8754091 2026-12-28 Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-2666 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-3842 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-3843 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-3844 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-3845 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8957079 2026-12-28 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 9181257 2026-12-28 Drug substance 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-3844 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-3843 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-3842 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-2666 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-3845 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 7514444*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8697711*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8735403*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8754091*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8957079*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 9181257*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8008309 2027-11-13 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8008309*PED 2028-05-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 10004746 2031-06-03 U-3846 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 10004746 2031-06-03 U-3848 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 10004746 2031-06-03 U-3849 2024-03-19 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 102 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57962-007 Imbruvica Ibrutinib Pharmacyclics LLC NDA Current 57962-007 Imbruvica Ibrutinib Pharmacyclics LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 83995 SUPPL 2025-10-31 83883 SUPPL 2025-10-23 80732 SUPPL 2024-12-26 80728 SUPPL 2024-12-26 78464 SUPPL 2024-05-14 77610 SUPPL 2024-02-23 77609 SUPPL 2024-02-23 74474 ORIG 2023-06-12 73810 ORIG 2023-03-21 71891 ORIG 2022-08-25