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 44 .
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 2026-10-15 13:18:30 2026-09 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 84e616aacf4f…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 2 of 46 · 1,811 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N217003-001 10004746 2031-06-03 U-3847 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10016435 2031-06-03 U-3845 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10478439 2031-06-03 U-3422 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10478439 2031-06-03 U-3842 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10478439 2031-06-03 U-3844 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10478439 2031-06-03 U-2666 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10478439 2031-06-03 U-2970 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10478439 2031-06-03 U-3843 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10478439 2031-06-03 U-3845 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10751342 2031-06-03 U-2666 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10751342 2031-06-03 U-3844 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10751342 2031-06-03 U-3843 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10751342 2031-06-03 U-3842 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 11672803 2031-06-03 U-2666 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 11672803 2031-06-03 U-3842 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 11672803 2031-06-03 U-3844 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 11672803 2031-06-03 U-3843 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 8999999 2031-06-03 U-2666 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 8999999 2031-06-03 U-3842 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 8999999 2031-06-03 U-3843 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 8999999 2031-06-03 U-3844 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9125889 2031-06-03 U-3845 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9801881 2031-06-03 U-3846 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9801881 2031-06-03 U-3847 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9801883 2031-06-03 U-2666 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9801883 2031-06-03 U-3842 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9801883 2031-06-03 U-3843 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9801883 2031-06-03 U-3844 2024-03-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10478439*PED 2031-12-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10106548 2033-06-03 Drug substance, Drug product 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10125140 2033-06-03 Drug substance, Drug product 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10961251 2033-06-03 Drug product 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9725455 2033-06-03 Drug substance 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9296753 2033-10-30 Drug substance 2022-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10106548*PED 2033-12-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10125140*PED 2033-12-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10961251*PED 2033-12-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9725455*PED 2033-12-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 9296753*PED 2034-04-30 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N217003-001 10463668 2034-10-24 U-2970 2024-03-19 c2088c7a36db…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 110 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.
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 · 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