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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021986
Company: BRISTOL MYERS SQUIBB

Products on NDA 21986

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPRYCEL	DASATINIB	20MG	TABLET;ORAL	Prescription	None	Yes	No
SPRYCEL	DASATINIB	50MG	TABLET;ORAL	Prescription	None	Yes	No
SPRYCEL	DASATINIB	70MG	TABLET;ORAL	Prescription	None	Yes	No
SPRYCEL	DASATINIB	100MG	TABLET;ORAL	Prescription	None	Yes	Yes
SPRYCEL	DASATINIB	80MG	TABLET;ORAL	Prescription	None	Yes	No
SPRYCEL	DASATINIB	140MG	TABLET;ORAL	Prescription	None	Yes	No

Labels for NDA 021986

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2023	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf
06/29/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021986s025lbl.pdf
12/21/2018	SUPPL-21	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf
11/15/2018	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s023lbl.pdf
11/09/2017	SUPPL-20	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s020lbl.pdf
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

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