Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021986
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPRYCEL DASATINIB 20MG TABLET;ORAL Prescription AB Yes No
SPRYCEL DASATINIB 50MG TABLET;ORAL Prescription AB Yes No
SPRYCEL DASATINIB 70MG TABLET;ORAL Prescription AB Yes No
SPRYCEL DASATINIB 100MG TABLET;ORAL Prescription AB Yes Yes
SPRYCEL DASATINIB 80MG TABLET;ORAL Prescription None Yes No
SPRYCEL DASATINIB 140MG TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/28/2006 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021986s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021986_022072_SprycelTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021986Orig1s019ltr.pdf
09/27/2016 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021986s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021986Orig1s018ltr.pdf
08/12/2015 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf
08/12/2015 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf
01/26/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/10/2014 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021986s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021986Orig1s014ltr.pdf
06/17/2013 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021986s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021986Orig1s013ltr.pdf
10/07/2011 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf
10/07/2011 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf
10/28/2010 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s008ltr.pdf
10/28/2010 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s007ltr.pdf
07/28/2010 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022072s002,021986s005ltr.pdf
05/21/2009 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021986s004ltr.pdf
05/30/2008 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021986s003,022072s001ltr.pdf
11/08/2007 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021986s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf
11/08/2007 SUPPL-1 Efficacy-New Dosing Regimen Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s019lbl.pdf
09/27/2016 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021986s018lbl.pdf
08/12/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf
08/12/2015 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf
04/10/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021986s014lbl.pdf
06/17/2013 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021986s013lbl.pdf
10/07/2011 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf
10/07/2011 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf
10/28/2010 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf
10/28/2010 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf
07/28/2010 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s005lbl.pdf
05/21/2009 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s004lbl.pdf
11/08/2007 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021986s001s002lbl.pdf
06/28/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf

SPRYCEL

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription No AB 202103 APOTEX INC
SPRYCEL DASATINIB 20MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription No AB 202103 APOTEX INC
SPRYCEL DASATINIB 50MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 70MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription No AB 202103 APOTEX INC
SPRYCEL DASATINIB 70MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 100MG TABLET;ORAL Prescription No AB 202103 APOTEX INC
SPRYCEL DASATINIB 100MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

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