GILEAD SCIENCES INC FDA Approval NDA 203100

Application #203100

Documents

Letter	2013-10-08
Letter	2014-12-18
Label	2012-08-28
Label	2013-10-08
Label	2014-12-19
Label	2016-02-23
Review	2012-10-10
Letter	2012-08-29
Letter	2013-10-25
Letter	2014-09-02
Letter	2015-07-30
Letter	2016-02-23
Label	2013-10-25
Label	2014-09-03
Label	2015-07-30
Summary Review	2012-10-10
Letter	2016-09-19
Label	2016-09-15
Label	2017-01-27
Letter	2017-01-31
Label	2017-04-10
Letter	2017-04-12
Label	2017-05-05
Letter	2017-05-09
Letter	2017-08-31
Label	2017-08-31
Pediatric CDTL Review	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Label	2018-08-09
Letter	2018-08-10
Label	2018-11-06
Letter	2018-11-13
Label	2019-02-07
Letter	2019-02-14
Letter	2020-08-24
Label	2020-09-02
Letter	2021-09-10
Label	2021-09-13

Application Sponsors

NDA 203100

GILEAD SCIENCES INC

Marketing Status

Prescription

001

Application Products

001

TABLET;ORAL

150MG;150MG;200MG;300MG

STRIBILD

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2012-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-05-03	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2013-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2013-11-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	2013-10-23	901 REQUIRED
EFFICACY; Efficacy	SUPPL	10	AP	2014-08-28	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2014-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2015-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2015-06-08	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2015-08-10	STANDARD
LABELING; Labeling	SUPPL	21	AP	2016-02-19	STANDARD
LABELING; Labeling	SUPPL	24	AP	2016-09-15	901 REQUIRED
EFFICACY; Efficacy	SUPPL	25	AP	2017-01-27	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2017-04-07	STANDARD
LABELING; Labeling	SUPPL	29	AP	2017-05-04	STANDARD
LABELING; Labeling	SUPPL	30	AP	2017-08-30	STANDARD
LABELING; Labeling	SUPPL	32	AP	2018-08-07	STANDARD
LABELING; Labeling	SUPPL	33	AP	2018-11-02	STANDARD
LABELING; Labeling	SUPPL	34	AP	2019-02-06	STANDARD
LABELING; Labeling	SUPPL	35	AP	2020-08-21	STANDARD
LABELING; Labeling	SUPPL	36	AP	2021-09-09	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	4	Null	7
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	6
SUPPL	10	Null	6
SUPPL	11	Null	6
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	15
SUPPL	17	Null	0
SUPPL	21	Null	6
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	28	Null	7
SUPPL	29	Null	15
SUPPL	30	Null	6
SUPPL	32	Null	15
SUPPL	33	Null	15
SUPPL	34	Null	6
SUPPL	35	Null	6
SUPPL	36	Null	7

CDER Filings

GILEAD SCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203100
            [companyName] => GILEAD SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"STRIBILD","activeIngredients":"COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"150MG;150MG;200MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/06\/2019","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203100s034lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203100s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203100s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2018","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203100s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2017","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s030lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2017","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s029lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2017","submission":"SUPPL-29","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s029lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2017","submission":"SUPPL-25","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203100s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203100s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203100s021lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203100s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203100s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2014","submission":"SUPPL-11","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203100s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203100s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203100s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2013","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203100s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203100s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203100s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/0203100Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203100Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203100Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/06\/2019","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203100s034lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203100Orig1s034ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203100s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203100Orig1s33ltr.pdf\"}]","notes":">"},{"actionDate":"08\/07\/2018","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203100s032lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203100Orig1s032ltr.pdf\"}]","notes":">"},{"actionDate":"08\/30\/2017","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203100Orig1s030ltr.pdf\"}]","notes":">"},{"actionDate":"05\/04\/2017","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s029lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203100Orig1s029ltr.pdf\"}]","notes":">"},{"actionDate":"04\/07\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s028lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203100Orig1s028ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2017","submission":"SUPPL-25","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203100s025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203100Orig1s025ltr.pdf\"}]","notes":">"},{"actionDate":"09\/15\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203100s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203100Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"02\/19\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203100s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203100Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"08\/10\/2015","submission":"SUPPL-17","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/28\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203100s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203100Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"06\/08\/2015","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/07\/2015","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/17\/2014","submission":"SUPPL-11","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203100s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203100Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2014","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203100s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203100Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"10\/23\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203100s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203100Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/08\/2013","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/16\/2013","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/19\/2013","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/02\/2013","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203100s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203100Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/03\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/15\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-02-06
        )

)

NDA 203100

GILEAD SCIENCES INC

FDA Drug Application

Application #203100

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

GILEAD SCIENCES INC