VIIV HLTHCARE FDA Approval NDA 021548

Application #021548

Documents

Letter	2003-10-27
Letter	2004-12-02
Letter	2005-11-18
Letter	2006-03-23
Letter	2006-08-09
Letter	2006-11-22
Letter	2007-10-22
Letter	2008-01-09
Letter	2008-01-09
Letter	2008-02-22
Letter	2009-04-20
Letter	2010-04-29
Letter	2012-02-27
Letter	2015-07-20
Letter	2015-04-01
Label	2003-10-27
Label	2004-12-03
Label	2005-06-14
Label	2005-11-17
Label	2006-03-14
Label	2006-08-09
Label	2007-02-21
Label	2006-11-16
Label	2007-10-15
Label	2007-12-14
Label	2007-12-27
Label	2008-02-25
Label	2008-03-07
Label	2009-09-18
Label	2011-05-16
Label	2012-05-01
Label	2012-02-22
Label	2013-02-14
Label	2015-07-22
Label	2016-03-23
Review	2004-10-26
Letter	2005-06-14
Letter	2006-05-16
Letter	2007-02-12
Letter	2008-03-07
Letter	2008-05-05
Letter	2009-10-26
Letter	2011-05-16
Letter	2012-05-02
Letter	2013-02-14
Letter	2016-03-24
Label	2006-05-16
Label	2010-05-03
Label	2015-04-02
Letter	2016-09-20
Label	2016-09-27
Label	2017-12-05
Letter	2017-12-05
Pediatric Written Request	2012-01-10
Pediatric Amendment 1	2012-01-10
Pediatric Amendment 2	2012-01-10
Pediatric Amendment 3	2012-01-10
Pediatric Amendment 4	2012-01-10
Pediatric Amendment 5	2012-01-10
Pediatric Clinical Pharmacology Review	2012-01-10
Pediatric Medical Review	2012-01-10
Letter	2019-03-29
Label	2019-04-02

Application Sponsors

NDA 021548

VIIV HLTHCARE

Marketing Status

Prescription

001

Application Products

001

TABLET;ORAL

EQ 700MG BASE

LEXIVA

FOSAMPRENAVIR CALCIUM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2003-10-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2004-11-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2005-06-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2005-11-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	2006-03-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-05-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2006-08-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	2007-02-07	STANDARD
LABELING; Labeling	SUPPL	11	AP	2006-11-14	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2007-10-12	UNKNOWN
LABELING; Labeling	SUPPL	14	AP	2007-12-13	STANDARD
LABELING; Labeling	SUPPL	15	AP	2007-12-14	STANDARD
LABELING; Labeling	SUPPL	16	AP	2008-02-20	STANDARD
LABELING; Labeling	SUPPL	17	AP	2008-03-05	STANDARD
LABELING; Labeling	SUPPL	19	AP	2008-04-30	STANDARD
LABELING; Labeling	SUPPL	20	AP	2009-04-14	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-09-11	STANDARD
LABELING; Labeling	SUPPL	24	AP	2010-04-26	UNKNOWN
LABELING; Labeling	SUPPL	26	AP	2011-05-10	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	2012-04-27	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2012-02-17	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2013-08-28	STANDARD
LABELING; Labeling	SUPPL	31	AP	2013-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2013-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2013-10-29	STANDARD
LABELING; Labeling	SUPPL	35	AP	2015-07-17	STANDARD
LABELING; Labeling	SUPPL	36	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	37	AP	2016-03-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2016-03-10	STANDARD
LABELING; Labeling	SUPPL	39	AP	2016-09-15	901 REQUIRED
LABELING; Labeling	SUPPL	40	AP	2017-12-01	STANDARD
LABELING; Labeling	SUPPL	41	AP	2019-03-28	STANDARD

Submissions Property Types

SUPPL	21	Null	7
SUPPL	24	Null	7
SUPPL	26	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	7
SUPPL	30	Null	0
SUPPL	31	Null	6
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	37	Null	6
SUPPL	38	Null	0
SUPPL	39	Null	6
SUPPL	40	Null	6
SUPPL	41	Null	6

TE Codes

001

Prescription

CDER Filings

VIIV HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21548
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEXIVA","activeIngredients":"FOSAMPRENAVIR CALCIUM","strength":"EQ 700MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/28\/2019","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021548s041,022116s025lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2019","submission":"SUPPL-41","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021548s041,022116s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021548s040lbledt.pdf\"}]","notes":""},{"actionDate":"12\/01\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021548s026,022116s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2011","submission":"SUPPL-26","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021548s026,022116s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2010","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021548s024,022116s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021548s021,022116s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2008","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021548s017,022116s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021548s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2007","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021548s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2007","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021548s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2007","submission":"SUPPL-13","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021548s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2007","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21548_levixa_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEXIVA","submission":"FOSAMPRENAVIR CALCIUM","actionType":"EQ 700MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-28
        )

)

NDA 021548

VIIV HLTHCARE

FDA Drug Application

Application #021548

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

VIIV HLTHCARE