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SPRYCEL

dasatinib · Tablet

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
SPRYCEL
Generic name
dasatinib
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
E.R. Squibb & Sons, L.L.C.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
6
Packages
6
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dasatinib 100 mg/1 643105 View
Dasatinib 140 mg/1 643105 View
Dasatinib 20 mg/1 643105 View
Dasatinib 50 mg/1 643105 View
Dasatinib 70 mg/1 643105 View
Dasatinib 80 mg/1 643105 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 3A4 Inhibitors [MoA] MoA All 118 members
Kinase Inhibitor [EPC] EPC All 89 members
Protein Kinase Inhibitors [MoA] MoA All 41 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021986
Application type
NDA · New Drug Application
Approval date
June 28, 2006
Sponsor
BRISTOL MYERS SQUIBB
Products on application
6
Submissions recorded
23
Products approved under application 021986.
Product Trade name Form Strength Ingredient Status TE Flags
021986-001 SPRYCEL TABLET DASATINIB Prescription AB RLD
021986-002 SPRYCEL TABLET DASATINIB Prescription AB RLD
021986-003 SPRYCEL TABLET DASATINIB Prescription AB RLD
021986-004 SPRYCEL TABLET DASATINIB Prescription AB RLD RS
021986-005 SPRYCEL TABLET DASATINIB Prescription AB RLD
021986-006 SPRYCEL TABLET DASATINIB Prescription AB RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
7491725 March 28, 2026 001 Yes —
7491725 March 28, 2026 002 Yes —
7491725 March 28, 2026 003 Yes —
7491725 March 28, 2026 004 Yes —
7491725 March 28, 2026 005 Yes —
7491725 March 28, 2026 006 Yes —
7491725*PED September 28, 2026 001 No —
7491725*PED September 28, 2026 002 No —
7491725*PED September 28, 2026 003 No —
7491725*PED September 28, 2026 004 No —
7491725*PED September 28, 2026 005 No —
7491725*PED September 28, 2026 006 No —
Regulatory exclusivity periods.
Code Expires Product
ODE-225 December 21, 2025 001
ODE-225 December 21, 2025 002
ODE-225 December 21, 2025 003
ODE-225 December 21, 2025 004
ODE-225 December 21, 2025 005
ODE-225 December 21, 2025 006
PED June 21, 2026 001
PED June 21, 2026 002
PED June 21, 2026 003
PED June 21, 2026 004
PED June 21, 2026 005
PED June 21, 2026 006

Approval history

Source: Drugs@FDA
Most recent submissions on application 021986.
Type No. Action Status Date Review
Supplement 28 Labeling Approved July 31, 2024 Standard
Supplement 27 Labeling Approved February 8, 2023 Standard
Supplement 25 Labeling Approved June 29, 2021 Standard
Supplement 21 Efficacy Approved December 21, 2018 Priority
Supplement 23 Labeling Approved November 15, 2018 Standard
Supplement 20 Efficacy Approved November 9, 2017 Priority
Supplement 19 Labeling Approved August 10, 2017 Standard
Supplement 18 Labeling Approved September 27, 2016 Standard
Supplement 17 Labeling Approved August 12, 2015 Standard
Supplement 16 Efficacy Approved August 12, 2015 Standard
Supplement 15 Manufacturing (CMC) Approved January 26, 2015 Priority
Supplement 14 Labeling Approved April 10, 2014 Standard
Supplement 13 Efficacy Approved June 17, 2013 Standard
Supplement 10 Labeling Approved October 7, 2011 Unknown
Supplement 9 Labeling Approved October 7, 2011 Unknown
Supplement 8 Efficacy Approved October 28, 2010 Priority
Supplement 7 Efficacy Approved October 28, 2010 Standard
Supplement 5 Labeling Approved July 28, 2010 Standard
Supplement 4 Efficacy Approved May 21, 2009 Unknown
Supplement 3 Manufacturing (CMC) Approved May 30, 2008 N/A
Supplement 2 Efficacy Approved November 8, 2007 Unknown
Supplement 1 Efficacy Approved November 8, 2007 Priority
Original application 1 Type 1 - New Molecular Entity Approved June 28, 2006 Priority

Review documents

  • 0 · Supplement · June 8, 2026
  • 0 · Supplement · August 2, 2024
  • 0 · Supplement · August 2, 2024
  • 0 · Supplement · February 9, 2023
  • 0 · Supplement · February 9, 2023
  • 0 · Supplement · June 30, 2021
  • 0 · Supplement · June 30, 2021
  • 0 · Supplement · December 30, 2018
  • 0 · Supplement · December 26, 2018
  • 0 · Supplement · December 7, 2018
  • 0 · Supplement · November 23, 2018
  • 0 · Supplement · November 15, 2017
  • 0 · Supplement · November 14, 2017
  • 0 · Supplement · August 15, 2017
  • 0 · Supplement · August 14, 2017
  • 0 · Supplement · September 30, 2016
  • 0 · Supplement · September 29, 2016
  • 0 · Supplement · August 14, 2015
  • 0 · Supplement · August 14, 2015
  • 0 · Supplement · August 13, 2015
  • 0 · Supplement · August 13, 2015
  • 0 · Supplement · May 12, 2014
  • 0 · Supplement · April 14, 2014
  • 0 · Supplement · June 18, 2013
  • 0 · Supplement · June 17, 2013
  • 0 · Supplement · October 13, 2011
  • 0 · Supplement · October 13, 2011
  • 0 · Supplement · October 12, 2011
  • 0 · Supplement · October 12, 2011
  • 0 · Supplement · September 22, 2011

Adverse event reports

Source: openFDA FAERS
9,103
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DASATINIB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0003-0524-11 0003-0524 E.R. Squibb & Sons, L.L.C. 1 BOTTLE in 1 CARTON (0003-0524-11) / 60 TABLET in 1 BOTTLE June 27, 2006
0003-0527-11 0003-0527 E.R. Squibb & Sons, L.L.C. 1 BOTTLE in 1 CARTON (0003-0527-11) / 60 TABLET in 1 BOTTLE June 27, 2006
0003-0528-11 0003-0528 E.R. Squibb & Sons, L.L.C. 1 BOTTLE in 1 CARTON (0003-0528-11) / 60 TABLET in 1 BOTTLE June 27, 2006
0003-0852-22 0003-0852 E.R. Squibb & Sons, L.L.C. 1 BOTTLE in 1 CARTON (0003-0852-22) / 30 TABLET in 1 BOTTLE May 30, 2008
0003-0855-22 0003-0855 E.R. Squibb & Sons, L.L.C. 1 BOTTLE in 1 CARTON (0003-0855-22) / 30 TABLET in 1 BOTTLE October 28, 2010
0003-0857-22 0003-0857 E.R. Squibb & Sons, L.L.C. 1 BOTTLE in 1 CARTON (0003-0857-22) / 30 TABLET in 1 BOTTLE October 28, 2010
0003-0524 0003-0524 E.R. Squibb & Sons, L.L.C. — June 27, 2006
0003-0527 0003-0527 E.R. Squibb & Sons, L.L.C. — June 27, 2006
0003-0528 0003-0528 E.R. Squibb & Sons, L.L.C. — June 27, 2006
0003-0852 0003-0852 E.R. Squibb & Sons, L.L.C. — May 30, 2008
0003-0855 0003-0855 E.R. Squibb & Sons, L.L.C. — October 28, 2010
0003-0857 0003-0857 E.R. Squibb & Sons, L.L.C. — October 28, 2010

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.