Home Applications 217729 Application 217729
Type NDA
Sponsor PF PRISM CV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BOSULIF BOSUTINIB MONOHYDRATE CAPSULE;ORAL EQ 50MG BASE Yes No 002 BOSULIF BOSUTINIB MONOHYDRATE CAPSULE;ORAL EQ 100MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N217729-001 BOSULIF BOSUTINIB MONOHYDRATE EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 N217729-002 BOSULIF BOSUTINIB MONOHYDRATE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217729-001 7417148 2025-12-11 U-3707 2023-10-26 N217729-001 7417148 2025-12-11 U-3708 2023-10-26 N217729-001 7919625 2025-12-11 Drug product 2023-10-26 N217729-001 7417148*PED 2026-06-11 Pediatric extension N217729-001 7919625*PED 2026-06-11 Pediatric extension N217729-001 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 N217729-001 7767678*PED 2027-05-23 Pediatric extension N217729-001 11103497 2034-02-28 U-3216 2023-10-26 N217729-001 11103497 2034-02-28 U-3217 2023-10-26 N217729-001 11103497*PED 2034-08-28 Pediatric extension N217729-002 7417148 2025-12-11 U-3707 2023-10-26 N217729-002 7417148 2025-12-11 U-3708 2023-10-26 N217729-002 7919625 2025-12-11 Drug product 2023-10-26 N217729-002 7417148*PED 2026-06-11 Pediatric extension N217729-002 7919625*PED 2026-06-11 Pediatric extension N217729-002 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 N217729-002 7767678*PED 2027-05-23 Pediatric extension N217729-002 11103497 2034-02-28 U-3216 2023-10-26 N217729-002 11103497 2034-02-28 U-3217 2023-10-26 N217729-002 11103497*PED 2034-08-28 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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 2026-02-19 14:30 UTC 2026-02 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD 2023-09-26 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 11 · 432 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217729-001 7417148 2025-12-11 U-3707 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7417148 2025-12-11 U-3708 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7919625 2025-12-11 Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7417148*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7919625*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7767678*PED 2027-05-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 11103497 2034-02-28 U-3216 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 11103497 2034-02-28 U-3217 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 11103497*PED 2034-08-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7417148 2025-12-11 U-3707 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7417148 2025-12-11 U-3708 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7919625 2025-12-11 Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7417148*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7919625*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7767678*PED 2027-05-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 11103497 2034-02-28 U-3216 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 11103497 2034-02-28 U-3217 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 11103497*PED 2034-08-28 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 7417148 2025-12-11 U-3707 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 7417148 2025-12-11 U-3708 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 7919625 2025-12-11 Drug product 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 7417148*PED 2026-06-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 7919625*PED 2026-06-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 7767678*PED 2027-05-23 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 11103497 2034-02-28 U-3216 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 11103497 2034-02-28 U-3217 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 11103497*PED 2034-08-28 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 7417148 2025-12-11 U-3707 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 7417148 2025-12-11 U-3708 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 7919625 2025-12-11 Drug product 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 7417148*PED 2026-06-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 7919625*PED 2026-06-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 7767678*PED 2027-05-23 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 11103497 2034-02-28 U-3216 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 11103497 2034-02-28 U-3217 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 11103497*PED 2034-08-28 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 152 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BOSULIF BOSUTINIB Pfizer Laboratories Div Pfizer Inc adc84ad5-a04d-4fee-9ba8-91f7abd928e3 2026-03-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 217729 application number: NDA217729
Documents# Document, Submission type, Date table Document Submission type Date 85288 SUPPL 2026-03-06 85265 SUPPL 2026-03-04 80523 SUPPL 2024-12-05 80503 SUPPL 2024-12-04 77635 ORIG 2024-02-28 75573 ORIG 2023-09-27 75571 ORIG 2023-09-27