GILEAD SCIENCES INC FDA Approval NDA 202123

NDA 202123

GILEAD SCIENCES INC

FDA Drug Application

Application #202123

Documents

Letter2012-08-15
Letter2013-10-25
Letter2014-06-10
Letter2014-09-17
Letter2016-02-25
Letter2016-02-25
Label2011-08-11
Label2013-01-30
Label2013-06-25
Label2013-12-17
Label2014-06-10
Label2015-05-12
Label2016-02-19
Letter2011-08-12
Letter2013-01-30
Letter2013-06-21
Letter2013-12-17
Letter2015-05-11
Letter2016-02-11
Label2012-08-15
Label2013-10-25
Label2014-10-02
Label2016-02-25
Review2012-09-06
Summary Review2012-09-06
Label2017-04-10
Letter2017-04-12
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Letter2018-10-31
Label2018-11-02
Letter2019-11-29
Label2019-12-02

Application Sponsors

NDA 202123GILEAD SCIENCES INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG;EQ 25MG BASE;300MG1COMPLERAEMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2011-08-10PRIORITY
EFFICACY; EfficacySUPPL3AP2013-01-25STANDARD
LABELING; LabelingSUPPL6AP2012-08-10901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2013-03-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2013-04-19PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2013-05-10PRIORITY
LABELING; LabelingSUPPL11AP2013-06-20STANDARD
EFFICACY; EfficacySUPPL12AP2013-12-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2013-11-08PRIORITY
LABELING; LabelingSUPPL15AP2013-10-23901 REQUIRED
LABELING; LabelingSUPPL16AP2014-06-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2014-07-11PRIORITY
LABELING; LabelingSUPPL18AP2014-09-16STANDARD
LABELING; LabelingSUPPL20AP2015-05-05901 REQUIRED
EFFICACY; EfficacySUPPL21AP2016-02-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2015-12-29PRIORITY
LABELING; LabelingSUPPL23AP2016-02-09STANDARD
LABELING; LabelingSUPPL24AP2016-02-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2016-03-09PRIORITY
LABELING; LabelingSUPPL27AP2017-04-07STANDARD
EFFICACY; EfficacySUPPL29AP2018-10-31STANDARD
LABELING; LabelingSUPPL31AP2019-11-27STANDARD

Submissions Property Types

ORIG1Null6
SUPPL3Null7
SUPPL6Null6
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL11Null7
SUPPL12Null7
SUPPL14Null0
SUPPL15Null15
SUPPL16Null31
SUPPL17Null0
SUPPL18Null15
SUPPL20Null7
SUPPL21Null15
SUPPL22Null0
SUPPL23Null15
SUPPL24Null15
SUPPL26Null0
SUPPL27Null15
SUPPL29Null15
SUPPL31Null15

CDER Filings

GILEAD SCIENCES INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202123
            [companyName] => GILEAD SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"COMPLERA","activeIngredients":"EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG;EQ 25MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/27\/2019","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202123s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2018","submission":"SUPPL-29","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202123s029lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2017","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202123s027lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202123s021s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202123s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202123s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202123s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202123s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202123s016lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202123s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2013","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2013","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202123s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202123s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/10\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202123s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202123s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202123_compleratm_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202123Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/27\/2019","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202123s031lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/202123Orig1s031ltr.pdf\"}]","notes":">"},{"actionDate":"10\/31\/2018","submission":"SUPPL-29","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202123s029lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202123Orig1s029ltr.pdf\"}]","notes":">"},{"actionDate":"04\/07\/2017","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202123s027lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202123Orig1s027ltr.pdf\"}]","notes":">"},{"actionDate":"03\/09\/2016","submission":"SUPPL-26","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202123s021s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202123Orig1s021,s024.pdf\"}]","notes":">"},{"actionDate":"02\/09\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202123s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202123Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"12\/29\/2015","submission":"SUPPL-22","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2016","submission":"SUPPL-21","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202123Orig1s021,s024.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/05\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202123s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202123Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"09\/16\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202123s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202123Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"07\/11\/2014","submission":"SUPPL-17","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/05\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202123s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202123Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"10\/23\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202123Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"11\/08\/2013","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2013","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202123Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"06\/20\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202123Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"05\/10\/2013","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/19\/2013","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/26\/2013","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/10\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202123s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202123Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"01\/25\/2013","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202123s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202123Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-11-27
        )

)
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