BRISTOL MYERS SQUIBB FDA Approval NDA 206352

NDA 206352

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #206352

Documents

Letter2014-06-03
Letter2015-04-01
Label2014-06-03
Label2015-12-10
Review2015-04-07
Summary Review2015-04-07
Letter2015-09-28
Label2015-04-02
Label2016-09-15
Letter2016-09-20
Letter2017-05-25
Label2017-05-25
Letter2017-10-23
Label2017-10-24
Pediatric Medical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-04-19
Letter2018-04-20
Letter2020-09-25
Label2020-09-25

Application Sponsors

NDA 206352BRISTOL MYERS SQUIBB

Marketing Status

Prescription001

Application Products

001POWDER;ORALEQ 50MG BASE/PACKET1REYATAZATAZANAVIR SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2014-06-02PRIORITY
LABELING; LabelingSUPPL2AP2015-03-27901 REQUIRED
EFFICACY; EfficacySUPPL3AP2015-09-24PRIORITY
LABELING; LabelingSUPPL4AP2016-09-15901 REQUIRED
EFFICACY; EfficacySUPPL5AP2017-05-23STANDARD
LABELING; LabelingSUPPL6AP2017-10-20STANDARD
LABELING; LabelingSUPPL7AP2018-04-18STANDARD
LABELING; LabelingSUPPL8AP2020-09-24STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null15
SUPPL3Null6
SUPPL4Null7
SUPPL5Null7
SUPPL6Null15
SUPPL7Null6
SUPPL8Null6

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206352
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"REYATAZ","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 50MG BASE\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/18\/2018","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021567s042,206352s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021567s041,206352s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021567s040,206352s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021567s039,206352s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2015","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206352s003,021567s038lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021567s037,206352s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021567s037,206352s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206352s000,021567s035lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/02\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206352s000,021567s035lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/206352Orig1s000,21567Orig1s035ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206352Orig1s000_021567Orig1s035TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206352Orig1s000_021567Orig1s035SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/18\/2018","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021567s042,206352s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/021567Orig1s042,206352Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"10\/20\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021567s041,206352s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/021567Orig1s041,206352Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"05\/23\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021567s040,206352s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/021567Orig1s040,206352Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/15\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021567s039,206352s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/021567Orig1s039,206352Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/24\/2015","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206352s003,021567s038lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206352Orig1s003,021567Orig1s038ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021567s037,206352s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/021567Orig1s037,206352Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-04-18
        )

)
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