Home DailyMed 0194e889-8ac5-476a-8987-668e89a77eaa National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:30:12 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203341-001 BOSULIF BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 N203341-002 BOSULIF BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 N203341-003 BOSULIF BOSUTINIB MONOHYDRATE EQ 400MG BASE TABLET / ORAL AB RLD 2017-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 33 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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.
Product history page 1 of 4 · 129 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 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL AB RLD 2017-10-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL AB RLD 2017-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 301d65b070ca…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 29 · 1,134 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 N203341-001 7417148 2025-12-11 U-1283 2012-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 7417148 2025-12-11 U-3708 2012-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 7417148 2025-12-11 U-3707 2012-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 7919625 2025-12-11 Drug product 2012-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 7417148*PED 2026-06-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 7919625*PED 2026-06-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 7767678 2026-11-23 Drug substance, Drug product 2012-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 7767678*PED 2027-05-23 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 11103497 2034-02-28 U-3216 2021-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 11103497 2034-02-28 U-3217 2021-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-001 11103497*PED 2034-08-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 7417148 2025-12-11 U-1283 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 7417148 2025-12-11 U-3707 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 7417148 2025-12-11 U-3708 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 7919625 2025-12-11 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 7417148*PED 2026-06-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 7919625*PED 2026-06-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 7767678 2026-11-23 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 7767678*PED 2027-05-23 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 11103497 2034-02-28 U-3216 2021-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 11103497 2034-02-28 U-3217 2021-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-002 11103497*PED 2034-08-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 7417148 2025-12-11 U-1283 2017-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 7417148 2025-12-11 U-3708 2017-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 7417148 2025-12-11 U-3707 2017-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 7919625 2025-12-11 Drug product 2017-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 7417148*PED 2026-06-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 7919625*PED 2026-06-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 7767678 2026-11-23 Drug substance, Drug product 2017-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 7767678*PED 2027-05-23 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 11103497 2034-02-28 U-3216 2021-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 11103497 2034-02-28 U-3217 2021-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203341-003 11103497*PED 2034-08-28 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203341-001 7417148 2025-12-11 U-1283 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7417148 2025-12-11 U-3708 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7417148 2025-12-11 U-3707 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7919625 2025-12-11 Drug product 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7417148*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7919625*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7767678 2026-11-23 Drug substance, Drug product 2012-09-25 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 12 · 453 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.