GILEAD SCIENCES FDA Approval NDA 021937

NDA 021937

GILEAD SCIENCES

FDA Drug Application

Application #021937

Documents

Letter2010-01-15
Letter2010-08-11
Letter2011-09-20
Letter2012-06-18
Letter2013-10-25
Letter2015-01-26
Letter2015-11-23
Letter2016-02-12
Label2006-07-12
Label2010-08-10
Label2012-06-18
Label2013-10-25
Review2006-12-13
Letter2006-07-21
Letter2008-02-20
Letter2008-03-04
Letter2008-06-09
Letter2008-10-23
Letter2013-04-23
Label2008-02-25
Label2008-03-05
Label2008-06-12
Label2010-01-08
Label2011-09-20
Label2013-04-19
Label2015-01-29
Label2015-12-03
Label2016-02-18
Label2017-04-10
Letter2017-04-12
Label2018-07-27
Letter2018-07-30
Label2019-10-30
Letter2019-10-30

Application Sponsors

NDA 021937GILEAD SCIENCES

Marketing Status

Prescription001

Application Products

001TABLET;ORAL600MG;200MG;300MG1ATRIPLAEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2006-07-12PRIORITY
LABELING; LabelingSUPPL6AP2008-02-15STANDARD
LABELING; LabelingSUPPL7AP2008-02-28STANDARD
EFFICACY; EfficacySUPPL9AP2008-06-06UNKNOWN
LABELING; LabelingSUPPL11AP2008-10-18STANDARD
EFFICACY; EfficacySUPPL12AP2010-01-07STANDARD
LABELING; LabelingSUPPL19AP2010-08-06UNKNOWN
LABELING; LabelingSUPPL23AP2011-09-16UNKNOWN
LABELING; LabelingSUPPL25AP2012-06-14STANDARD
LABELING; LabelingSUPPL27AP2013-04-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2013-11-08PRIORITY
LABELING; LabelingSUPPL31AP2013-10-23901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2014-07-11PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2014-11-26PRIORITY
LABELING; LabelingSUPPL34AP2015-01-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2015-01-12PRIORITY
LABELING; LabelingSUPPL37AP2015-11-20STANDARD
LABELING; LabelingSUPPL39AP2016-02-11STANDARD
LABELING; LabelingSUPPL41AP2017-04-07STANDARD
LABELING; LabelingSUPPL43AP2018-07-25STANDARD
LABELING; LabelingSUPPL44AP2019-10-29STANDARD

Submissions Property Types

ORIG1Null10
SUPPL12Null7
SUPPL19Null6
SUPPL23Null6
SUPPL25Null7
SUPPL27Null6
SUPPL30Null0
SUPPL31Null6
SUPPL32Null0
SUPPL33Null0
SUPPL34Null6
SUPPL35Null0
SUPPL37Null7
SUPPL39Null7
SUPPL41Null7
SUPPL43Null6
SUPPL44Null6

TE Codes

001PrescriptionAB

CDER Filings

GILEAD SCIENCES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21937
            [companyName] => GILEAD SCIENCES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATRIPLA","activeIngredients":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"600MG;200MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/29\/2019","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021937s044lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2018","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021937s043lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2017","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021937s041lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2016","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021937s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2015","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021937s037lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2015","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021937s034lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2015","submission":"SUPPL-34","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021937s034lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2013","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021937s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2013","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021937s027lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021937s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021937s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2011","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021937s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2010","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021937s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2010","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021937s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2008","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021937s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2008","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021937s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2008","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021937s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021937lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ATRIPLA","submission":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","actionType":"600MG;200MG;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-29
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.