VIIV HLTHCARE FDA Approval NDA 022116

NDA 022116

VIIV HLTHCARE

FDA Drug Application

Application #022116

Documents

Letter2007-07-05
Letter2009-04-20
Letter2009-10-26
Letter2010-04-29
Letter2012-02-27
Letter2015-07-20
Label2007-06-18
Label2008-03-07
Label2009-09-18
Label2011-05-16
Label2015-04-02
Label2016-03-23
Letter2008-03-07
Letter2008-05-05
Letter2011-05-16
Letter2012-05-02
Letter2013-02-14
Letter2015-04-01
Letter2016-03-24
Label2010-05-03
Label2012-05-01
Label2012-02-22
Label2013-02-14
Label2015-07-22
Review2009-11-10
Label2016-09-16
Letter2016-09-20
Label2017-12-05
Letter2017-12-05
Letter2019-03-29
Label2019-04-02

Application Sponsors

NDA 022116VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORALEQ 50MG BASE/ML1LEXIVAFOSAMPRENAVIR CALCIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2007-06-14PRIORITY
LABELING; LabelingSUPPL3AP2008-04-30STANDARD
LABELING; LabelingSUPPL4AP2009-04-14STANDARD
LABELING; LabelingSUPPL5AP2009-09-11STANDARD
LABELING; LabelingSUPPL8AP2010-04-26UNKNOWN
LABELING; LabelingSUPPL10AP2011-05-10STANDARD
EFFICACY; EfficacySUPPL12AP2012-04-27PRIORITY
LABELING; LabelingSUPPL13AP2012-02-17901 REQUIRED
LABELING; LabelingSUPPL15AP2013-02-12STANDARD
LABELING; LabelingSUPPL19AP2015-07-17STANDARD
LABELING; LabelingSUPPL20AP2015-03-27901 REQUIRED
LABELING; LabelingSUPPL21AP2016-03-22STANDARD
LABELING; LabelingSUPPL23AP2016-09-15STANDARD
LABELING; LabelingSUPPL24AP2017-12-01STANDARD
LABELING; LabelingSUPPL25AP2019-03-28STANDARD

Submissions Property Types

SUPPL5Null7
SUPPL8Null7
SUPPL10Null7
SUPPL12Null7
SUPPL13Null7
SUPPL15Null7
SUPPL19Null7
SUPPL20Null15
SUPPL21Null6
SUPPL23Null15
SUPPL24Null6
SUPPL25Null6

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22116
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEXIVA","activeIngredients":"FOSAMPRENAVIR CALCIUM","strength":"EQ 50MG BASE\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/28\/2019","submission":"SUPPL-25","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-25","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021548s041,022116s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022116s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022116s024lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022116s023lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022116s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021548s037,022116s021lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021548s035,022116s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021548s035,022116s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022116s020,021548s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022116s020,021548s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022116s020,021548s036lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2013","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021548s031,022116s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021548s031,022116s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2012","submission":"SUPPL-12","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021548s028,022116s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021548s029,022116s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021548s026,022116s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2011","submission":"SUPPL-10","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-8","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-5","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-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021548s017,022116s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022116lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEXIVA","submission":"FOSAMPRENAVIR CALCIUM","actionType":"EQ 50MG BASE\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-28
        )

)
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