NDA 021356

GILEAD SCIENCES INC

FDA Drug Application

Application #021356

Documents

• Letter: 2001-10-26
• Letter: 2002-12-02
• Letter: 2003-11-25
• Letter: 2004-07-06
• Letter: 2005-05-17
• Letter: 2006-03-23
• Letter: 2005-12-05
• Letter: 2007-05-29
• Letter: 2008-08-13
• Letter: 2008-11-06
• Letter: 2009-11-10
• Letter: 2010-01-25
• Letter: 2010-10-13
• Letter: 2011-09-21
• Letter: 2012-08-09
• Letter: 2012-08-20
• Letter: 2013-07-26
• Label: 2002-12-02
• Label: 2003-08-28
• Label: 2003-10-16
• Label: 2003-12-01
• Label: 2004-07-07
• Label: 2005-05-17
• Label: 2007-05-29
• Label: 2008-08-29
• Label: 2009-10-14
• Label: 2009-11-13
• Label: 2010-10-12
• Label: 2010-10-19
• Label: 2012-02-01
• Label: 2011-11-22
• Label: 2012-08-17
• Label: 2013-07-30
• Label: 2016-02-18
• Review: 2001-10-26
• Letter: 2003-08-28
• Letter: 2003-10-16
• Letter: 2008-05-21
• Letter: 2010-03-29
• Letter: 2010-10-19
• Letter: 2012-01-20
• Letter: 2011-11-22
• Letter: 2013-04-03
• Letter: 2013-10-25
• Letter: 2015-06-02
• Letter: 2016-02-18
• Label: 2001-10-26
• Label: 2006-03-10
• Label: 2005-12-05
• Label: 2008-11-07
• Label: 2010-03-26
• Label: 2011-09-20
• Label: 2012-08-08
• Label: 2013-04-09
• Label: 2013-10-25
• Label: 2015-06-04
• Label: 2017-04-10
• Letter: 2017-04-12
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Written Request: 2011-09-06
• Pediatric Amendment 1: 2011-09-06
• Pediatric Amendment 2: 2011-09-06
• Pediatric Amendment 3: 2011-09-06
• Pediatric Amendment 4: 2011-09-06
• Pediatric Amendment 5: 2011-09-06
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Amendment 2: 1900-01-01
• Pediatric Amendment 3: 1900-01-01
• Pediatric Amendment 4: 1900-01-01
• Pediatric Amendment 5: 1900-01-01
• Letter: 2018-07-30
• Label: 2018-07-31
• Label: 2018-12-12
• Letter: 2018-12-20
• Letter: 2019-04-24
• Label: 2019-04-25
• Pediatric Statistical Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 021356

GILEAD SCIENCES INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	300MG	1	VIREAD	TENOFOVIR DISOPROXIL FUMARATE
002	TABLET;ORAL	150MG	1	VIREAD	TENOFOVIR DISOPROXIL FUMARATE
003	TABLET;ORAL	200MG	1	VIREAD	TENOFOVIR DISOPROXIL FUMARATE
004	TABLET;ORAL	250MG	1	VIREAD	TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2001-10-26	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2003-08-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-10-14	STANDARD
LABELING; Labeling	SUPPL	6	AP	2003-10-31	STANDARD
LABELING; Labeling	SUPPL	10	AP	2004-07-01	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2005-05-12	UNKNOWN
EFFICACY; Efficacy	SUPPL	16	AP	2006-03-08	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2005-11-30	STANDARD
LABELING; Labeling	SUPPL	21	AP	2007-05-21	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2008-05-16	UNKNOWN
EFFICACY; Efficacy	SUPPL	25	AP	2008-08-11	STANDARD
LABELING; Labeling	SUPPL	26	AP	2008-11-04	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	2009-10-07	STANDARD
LABELING; Labeling	SUPPL	28	AP	2009-11-10	STANDARD
LABELING; Labeling	SUPPL	32	AP	2010-01-15	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	2010-03-24	PRIORITY
EFFICACY; Efficacy	SUPPL	34	AP	2010-10-01	STANDARD
EFFICACY; Efficacy	SUPPL	35	AP	2010-10-14	STANDARD
EFFICACY; Efficacy	SUPPL	37	AP	2011-09-19	STANDARD
EFFICACY; Efficacy	SUPPL	38	AP	2012-01-18	PRIORITY
EFFICACY; Efficacy	SUPPL	40	AP	2012-08-07	STANDARD
LABELING; Labeling	SUPPL	41	AP	2011-11-18	901 REQUIRED
EFFICACY; Efficacy	SUPPL	42	AP	2012-08-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2013-03-12	PRIORITY
EFFICACY; Efficacy	SUPPL	46	AP	2013-07-24	STANDARD
LABELING; Labeling	SUPPL	47	AP	2013-04-02	STANDARD
LABELING; Labeling	SUPPL	48	AP	2013-10-23	901 REQUIRED
EFFICACY; Efficacy	SUPPL	49	AP	2015-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	2015-11-18	PRIORITY
LABELING; Labeling	SUPPL	52	AP	2016-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	2016-03-10	PRIORITY
LABELING; Labeling	SUPPL	55	AP	2017-04-07	STANDARD
LABELING; Labeling	SUPPL	56	AP	2018-07-30	STANDARD
EFFICACY; Efficacy	SUPPL	57	AP	2018-12-11	PRIORITY
LABELING; Labeling	SUPPL	58	AP	2019-04-24	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	21	Null	41
SUPPL	25	Null	6
SUPPL	27	Null	7
SUPPL	28	Null	6
SUPPL	33	Null	31
SUPPL	34	Null	6
SUPPL	35	Null	6
SUPPL	37	Null	15
SUPPL	38	Null	6
SUPPL	40	Null	6
SUPPL	41	Null	6
SUPPL	42	Null	7
SUPPL	45	Null	0
SUPPL	46	Null	15
SUPPL	47	Null	6
SUPPL	48	Null	6
SUPPL	49	Null	6
SUPPL	51	Null	0
SUPPL	52	Null	6
SUPPL	53	Null	0
SUPPL	55	Null	7
SUPPL	56	Null	7
SUPPL	57	Null	15
SUPPL	58	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

GILEAD SCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21356
            [companyName] => GILEAD SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIREAD","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"VIREAD","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"VIREAD","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"VIREAD","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/24\/2019","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021356s058,022577s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2019","submission":"SUPPL-58","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021356s058,022577s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2018","submission":"SUPPL-57","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021356s057,022577s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2018","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021356s056,022577s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2017","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021356s055,022577s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2016","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021356s052,022577s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2015","submission":"SUPPL-49","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021356s047,022577s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2013","submission":"SUPPL-47","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021356s047,022577s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-42","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021356s042,022577s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2012","submission":"SUPPL-40","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021356s037lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2010","submission":"SUPPL-35","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021356s035lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2010","submission":"SUPPL-34","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021356s034lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2010","submission":"SUPPL-33","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021356s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2009","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021356s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2009","submission":"SUPPL-27","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021356s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2008","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021356s026lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2008","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021356s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2007","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021356s021,021752s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2006","submission":"SUPPL-16","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021356s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2005","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021356s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2005","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021356s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2004","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21356slr010_viread_lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2003","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21356slr001_Viread_lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21356lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIREAD","submission":"TENOFOVIR DISOPROXIL FUMARATE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIREAD","submission":"TENOFOVIR DISOPROXIL FUMARATE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIREAD","submission":"TENOFOVIR DISOPROXIL FUMARATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIREAD","submission":"TENOFOVIR DISOPROXIL FUMARATE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-04-24
        )

)