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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203341
Company: PF PRISM CV

Summary Review

Products on NDA 203341

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BOSULIF	BOSUTINIB MONOHYDRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
BOSULIF	BOSUTINIB MONOHYDRATE	EQ 500MG BASE	TABLET;ORAL	Prescription	None	Yes	No
BOSULIF	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203341

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203341Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203341_bosulif_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022090s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2024	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
09/26/2023	SUPPL-25	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203341Orig1s025ltr.pdf
04/20/2023	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203341Orig1s024ltr.pdf
05/14/2021	SUPPL-20	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203341s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203341Orig1s020ltr.pdf
06/17/2020	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203341s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203341Orig1s018ltr.pdf
10/09/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203341Orig1s017ltr.pdf
08/14/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203341Orig1s016ltr.pdf
10/18/2018	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203341s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203341Orig1s015ltr.pdf
05/01/2018	SUPPL-13	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203341Orig1s013ltr.pdf
12/19/2017	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203341s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s009ltr.pdf
04/13/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s007s008ltr.pdf
04/13/2017	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s007s008ltr.pdf
11/17/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s006ltr.pdf
04/04/2016	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s005ltr.pdf
10/08/2015	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
09/22/2015	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203341s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203341Orig1s003ltr.pdf
11/25/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203341s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203341Orig1s002ltr.pdf
09/30/2013	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203341s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203341Orig1s001ltr.pdf

Labels for NDA 203341

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2023	SUPPL-25	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s025lbl.pdf
04/20/2023	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s024lbl.pdf
05/14/2021	SUPPL-20	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203341s020lbl.pdf
06/17/2020	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203341s018lbl.pdf
10/09/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s017lbl.pdf
08/14/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s016lbl.pdf
10/18/2018	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203341s015lbl.pdf
12/19/2017	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203341s009lbl.pdf
04/13/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf
04/13/2017	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf
11/17/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s006lbl.pdf
04/04/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s005lbl.pdf
09/22/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203341s003lbl.pdf
11/25/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203341s002lbl.pdf
09/30/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203341s001lbl.pdf
09/04/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf

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