NDA 203341

PF PRISM CV

FDA Drug Application

Application #203341

Documents

• Letter: 2012-09-06
• Letter: 2015-09-24
• Label: 2012-09-04
• Label: 2015-10-06
• Label: 2016-04-05
• Review: 2012-09-13
• Summary Review: 2012-09-13
• Letter: 2013-10-01
• Letter: 2014-11-28
• Letter: 2016-04-06
• Label: 2013-09-30
• Label: 2015-01-05
• Letter: 2016-11-18
• Label: 2016-11-17
• Letter: 2017-04-14
• Letter: 2017-04-14
• Label: 2017-04-18
• Label: 2017-04-18
• Label: 2017-12-19
• Letter: 2017-12-27
• Letter: 2018-05-03
• Label: 2018-10-19
• Letter: 2018-10-23
• Letter: 2019-08-15
• Label: 2019-08-15
• Letter: 2019-10-10
• Label: 2019-10-10
• Letter: 2020-06-18
• Label: 2020-06-18
• Label: 2021-05-14
• Letter: 2021-05-17

Application Sponsors

NDA 203341

PF PRISM CV

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	EQ 100MG BASE	1	BOSULIF	BOSUTINIB MONOHYDRATE
002	TABLET;ORAL	EQ 500MG BASE	1	BOSULIF	BOSUTINIB MONOHYDRATE
003	TABLET;ORAL	EQ 400MG BASE	1	BOSULIF	BOSUTINIB MONOHYDRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-09-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2014-11-25
LABELING; Labeling	SUPPL	3	AP	2015-09-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-10-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-04-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-11-17	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2017-04-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-04-13	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2017-12-19	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2018-05-01	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-08-14	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-10-09	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-06-17	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2021-05-14	PRIORITY

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Orphan	5
SUPPL	5	Null	15
SUPPL	6	Null	6
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	7
SUPPL	13	Null	15
SUPPL	15	Orphan	5
SUPPL	16	Null	6
SUPPL	17	Null	7
SUPPL	18	Null	15
SUPPL	20	Null	7

CDER Filings

PF PRISM CV

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203341
            [companyName] => PF PRISM CV
            [docInserts] => ["",""]
            [products] => [{"drugName":"BOSULIF","activeIngredients":"BOSUTINIB MONOHYDRATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"BOSULIF","activeIngredients":"BOSUTINIB MONOHYDRATE","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BOSULIF","activeIngredients":"BOSUTINIB MONOHYDRATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/14\/2021","submission":"SUPPL-20","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203341s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203341s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/09\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203341s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203341s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2018","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203341s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2017","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203341s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/20334s007s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2017","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/20334s007s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203341s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203341s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203341s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203341s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203341s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203341lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/04\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203341lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203341Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203341_bosulif_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/022090s000_SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/14\/2021","submission":"SUPPL-20","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203341s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/203341Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"06\/17\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203341s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203341Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"10\/09\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203341s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203341Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"08\/14\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203341s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203341Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"10\/18\/2018","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203341s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203341Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"05\/01\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203341Orig1s013ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/19\/2017","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203341s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203341Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"04\/13\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/20334s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203341Orig1s007s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/13\/2017","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/20334s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203341Orig1s007s008ltr.pdf\"}]","notes":">"},{"actionDate":"11\/17\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203341s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203341Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"04\/04\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203341s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203341Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"10\/08\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203341s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203341Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"11\/25\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203341s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203341Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203341s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203341Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-05-14
        )

)