BRISTOL MYERS SQUIBB FDA Approval NDA 202155

Application #202155

Documents

Letter	2013-01-02
Letter	2014-09-10
Letter	2014-08-14
Letter	2015-09-14
Letter	2016-07-22
Letter	2016-03-04
Label	2012-12-31
Label	2014-01-31
Label	2014-03-19
Label	2013-11-19
Label	2014-09-09
Label	2015-06-19
Label	2015-09-11
Review	2013-02-13
Review	2014-03-21
Letter	2014-02-04
Letter	2014-03-14
Letter	2013-11-06
Letter	2015-06-18
Label	2014-08-13
Label	2016-07-21
Review	2016-05-03
Label	2017-11-30
Letter	2017-12-01
Label	2018-02-12
Letter	2018-02-14
Label	2018-07-05
Medication Guide	2018-07-06
Letter	2018-07-06
Label	2019-06-04
Medication Guide	2019-06-04
Letter	2019-06-05
Letter	2019-11-27
Label	2019-11-27
Medication Guide	2019-11-27
Letter	2021-04-22
Label	2021-04-22
Medication Guide	2021-04-22
Label	2021-10-13
Medication Guide	2021-10-13
Letter	2021-10-13

Application Sponsors

NDA 202155

BRISTOL MYERS SQUIBB

Marketing Status

Prescription	001
Prescription	002

Application Products

001	TABLET;ORAL	2.5MG	1	ELIQUIS	APIXABAN
002	TABLET;ORAL	5MG	1	ELIQUIS	APIXABAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-12-28	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2014-01-30	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2014-03-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2013-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2015-03-09	PRIORITY
EFFICACY; Efficacy	SUPPL	6	AP	2014-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2014-04-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-05-01	PRIORITY
REMS; REMS	SUPPL	9	AP	2014-08-12	N/A
LABELING; Labeling	SUPPL	10	AP	2015-06-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-09-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-07-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2016-05-03	PRIORITY
REMS; REMS	SUPPL	14	AP	2016-03-02	N/A
LABELING; Labeling	SUPPL	17	AP	2017-11-29	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-02-09	STANDARD
LABELING; Labeling	SUPPL	20	AP	2018-06-28	STANDARD
LABELING; Labeling	SUPPL	21	AP	2019-06-03	STANDARD
LABELING; Labeling	SUPPL	24	AP	2019-11-26	STANDARD
LABELING; Labeling	SUPPL	32	AP	2021-04-20	STANDARD
LABELING; Labeling	SUPPL	34	AP	2021-10-12	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15
SUPPL	3	Null	6
SUPPL	4	Null	7
SUPPL	5	Null	0
SUPPL	6	Null	15
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	6
SUPPL	10	Null	6
SUPPL	11	Null	6
SUPPL	12	Null	7
SUPPL	13	Null	0
SUPPL	14	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	31
SUPPL	24	Null	6
SUPPL	32	Null	7
SUPPL	34	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202155
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/202155s024lbl.pdf#page=37"]
            [products] => [{"drugName":"ELIQUIS","activeIngredients":"APIXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ELIQUIS","activeIngredients":"APIXABAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/26\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202155s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202155s021lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202155s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202155s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202155s017lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202155s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202155s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202155s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2014","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202155s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2014","submission":"SUPPL-9","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202155s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2014","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202155s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202155s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202155Orig1s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202155s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/28\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202155s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202155Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202155Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/26\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202155s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/202155Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"06\/03\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202155s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/202155Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"06\/28\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202155s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202155Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"02\/09\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202155s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202155Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"11\/29\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202155s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202155Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"03\/02\/2016","submission":"SUPPL-14","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202155Orig1s014ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2016","submission":"SUPPL-13","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/202155Orig1s013.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/20\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202155s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202155Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"09\/10\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202155s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202155Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202155s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202155Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"08\/12\/2014","submission":"SUPPL-9","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202155s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202155Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"05\/01\/2015","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/30\/2014","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/21\/2014","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202155s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202155Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/09\/2015","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202155Orig1s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202155Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"03\/13\/2014","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202155s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202155Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"01\/30\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202155s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202155Orig1s002ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/202155Orig1s002TOC.cfm\"}]","notes":">"},{"actionDate":"07\/16\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-26
        )

)

NDA 202155

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #202155

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

BRISTOL MYERS SQUIBB