NDA 206353

BRISTOL-MYERS SQUIBB

FDA Drug Application

Application #206353

Documents

• Letter: 2015-02-02
• Letter: 2015-07-24
• Letter: 2016-07-05
• Label: 2015-01-30
• Review: 2016-04-15
• Summary Review: 2016-04-15
• Label: 2015-07-24
• Label: 2016-07-05
• Letter: 2017-01-30
• Label: 2017-01-30
• Label: 2018-04-19
• Letter: 2018-04-23
• Label: 2020-04-23
• Letter: 2020-04-23
• Letter: 2020-08-03
• Label: 2020-08-03

Application Sponsors

NDA 206353

BRISTOL-MYERS SQUIBB

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 300MG BASE;150MG

1

EVOTAZ

ATAZANAVIR SULFATE; COBICISTAT

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2015-01-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2016-07-01	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2017-01-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2018-04-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-04-22	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2020-07-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	6

CDER Filings

BRISTOL-MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206353
            [companyName] => BRISTOL-MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVOTAZ","activeIngredients":"ATAZANAVIR SULFATE; COBICISTAT","strength":"EQ 300MG BASE;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206353s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206353s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206353s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206353s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206353s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206353s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206353s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206353s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206353s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/29\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206353s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206353Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206353Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206353Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206353s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206353Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"04\/22\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206353s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206353Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"04\/18\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206353s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206353Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206353s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206353Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"07\/01\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206353s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206353Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/23\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206353s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206353Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-07-31
        )

)