Home Applications 021986 Application 021986
Type NDA
Sponsor BRISTOL MYERS SQUIBB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SPRYCEL DASATINIB TABLET;ORAL 20MG Yes No 002 SPRYCEL DASATINIB TABLET;ORAL 50MG Yes No 003 SPRYCEL DASATINIB TABLET;ORAL 70MG Yes No 004 SPRYCEL DASATINIB TABLET;ORAL 100MG Yes Yes 005 SPRYCEL DASATINIB TABLET;ORAL 80MG Yes No 006 SPRYCEL DASATINIB TABLET;ORAL 140MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021986-001 SPRYCEL DASATINIB 20MG TABLET / ORAL AB RLD 2006-06-28 N021986-002 SPRYCEL DASATINIB 50MG TABLET / ORAL AB RLD 2006-06-28 N021986-003 SPRYCEL DASATINIB 70MG TABLET / ORAL AB RLD 2006-06-28 N021986-004 SPRYCEL DASATINIB 100MG TABLET / ORAL AB RLD, RS 2008-05-30 N021986-005 SPRYCEL DASATINIB 80MG TABLET / ORAL AB RLD 2010-10-28 N021986-006 SPRYCEL DASATINIB 140MG TABLET / ORAL AB RLD 2010-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021986-001 7491725 2026-03-28 Drug substance, Drug product N021986-001 7491725*PED 2026-09-28 Pediatric extension N021986-002 7491725 2026-03-28 Drug substance, Drug product N021986-002 7491725*PED 2026-09-28 Pediatric extension N021986-003 7491725 2026-03-28 Drug substance, Drug product N021986-003 7491725*PED 2026-09-28 Pediatric extension N021986-004 7491725 2026-03-28 Drug substance, Drug product N021986-004 7491725*PED 2026-09-28 Pediatric extension N021986-005 7491725 2026-03-28 Drug substance, Drug product N021986-005 7491725*PED 2026-09-28 Pediatric extension N021986-006 7491725 2026-03-28 Drug substance, Drug product N021986-006 7491725*PED 2026-09-28 Pediatric extension
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 7 · 258 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 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-005 SPRYCEL 80MG TABLET / ORAL AB RLD 2010-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021986-006 SPRYCEL 140MG TABLET / ORAL AB RLD 2010-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-001 SPRYCEL 20MG TABLET / ORAL AB RLD 2006-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-002 SPRYCEL 50MG TABLET / ORAL AB RLD 2006-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-003 SPRYCEL 70MG TABLET / ORAL AB RLD 2006-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021986-004 SPRYCEL 100MG TABLET / ORAL AB RLD, RS 2008-05-30 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Observed Orange Book patent history# Patent history page 1 of 32 · 1,272 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 N021986-001 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-001 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-002 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-002 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-003 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-003 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-004 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-004 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-005 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-005 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-006 7491725 2026-03-28 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021986-006 7491725*PED 2026-09-28 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021986-001 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-001 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-002 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-002 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-003 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-003 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-004 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-004 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-005 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-005 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-006 7491725 2026-03-28 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021986-006 7491725*PED 2026-09-28 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021986-001 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-001 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-002 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-002 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-003 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-003 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-004 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-004 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-005 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-005 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-006 7491725 2026-03-28 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021986-006 7491725*PED 2026-09-28 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 8680103 2025-02-04 Drug product 2014-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 8680103*PED 2025-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 7491725 2026-03-28 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021986-001 7491725*PED 2026-09-28 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 31 · 1,236 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 · 42 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0003-0524 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0524 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0524 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0524 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0524 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0524 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0524 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0527 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0527 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0527 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0527 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0527 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0527 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0527 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0528 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0528 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0528 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0528 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0528 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0528 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0528 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0852 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0852 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0852 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0852 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0852 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0852 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0852 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0855 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0855 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0855 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0855 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0855 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0855 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0855 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0857 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0857 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0857 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0857 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0857 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0857 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current 0003-0857 SPRYCEL dasatinib E.R. Squibb & Sons, L.L.C. NDA Current