VIIV HLTHCARE FDA Approval NDA 020596

NDA 020596

VIIV HLTHCARE

FDA Drug Application

Application #020596

Documents

Letter2002-06-24
Letter2003-11-25
Letter2006-11-06
Letter2011-11-22
Label2004-12-03
Label2011-12-02
Label2015-02-20
Review2007-09-26
Review2005-01-06
Review2007-09-26
Letter2001-03-06
Letter2002-10-08
Letter2002-03-01
Letter2004-12-02
Letter2004-10-04
Letter2006-06-20
Letter2015-03-26
Letter2015-02-24
Letter2015-10-02
Letter2016-07-22
Label2002-10-08
Label2002-06-24
Label2003-12-02
Label2004-10-04
Label2006-06-14
Label2006-10-26
Label2015-04-14
Label2015-10-07
Label2016-07-21
Review2007-09-26
Review2007-09-26
Review2007-09-26
Label2017-10-12
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2018-05-01
Label2018-05-07
Letter2019-05-14
Label2019-05-15

Application Sponsors

NDA 020596VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL10MG/ML1EPIVIRLAMIVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1995-11-17PRIORITY
EFFICACY; EfficacySUPPL2AP1997-04-11PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-11-13
LABELING; LabelingSUPPL4AP1997-12-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-02-03
LABELING; LabelingSUPPL6AP1997-12-15STANDARD
EFFICACY; EfficacySUPPL7AP1999-03-23STANDARD
LABELING; LabelingSUPPL8AP1999-03-08STANDARD
LABELING; LabelingSUPPL9AP1999-03-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1999-10-18
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1999-10-08
LABELING; LabelingSUPPL12AP2001-01-05STANDARD
LABELING; LabelingSUPPL13AP2001-03-06STANDARD
LABELING; LabelingSUPPL14AP2001-06-19STANDARD
LABELING; LabelingSUPPL15AP2002-10-08STANDARD
EFFICACY; EfficacySUPPL16AP2002-06-24STANDARD
LABELING; LabelingSUPPL17AP2002-03-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2002-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2002-12-24
LABELING; LabelingSUPPL20AP2003-11-13STANDARD
LABELING; LabelingSUPPL21AP2004-11-22STANDARD
LABELING; LabelingSUPPL22AP2004-09-29STANDARD
LABELING; LabelingSUPPL25AP2006-06-13STANDARD
LABELING; LabelingSUPPL27AP2006-10-25STANDARD
LABELING; LabelingSUPPL30AP2011-11-18901 REQUIRED
EFFICACY; EfficacySUPPL32AP2015-03-23STANDARD
LABELING; LabelingSUPPL33AP2015-02-19STANDARD
LABELING; LabelingSUPPL34AP2015-09-30STANDARD
EFFICACY; EfficacySUPPL35AP2016-07-20PRIORITY
LABELING; LabelingSUPPL36AP2017-09-25STANDARD
LABELING; LabelingSUPPL37AP2018-04-27STANDARD
LABELING; LabelingSUPPL38AP2019-05-10STANDARD

Submissions Property Types

ORIG1Null39
SUPPL3Null0
SUPPL5Null0
SUPPL10Null0
SUPPL11Null0
SUPPL15Null6
SUPPL18Null0
SUPPL19Null0
SUPPL20Null9
SUPPL30Null15
SUPPL32Null7
SUPPL33Null15
SUPPL34Null15
SUPPL35Null6
SUPPL36Null7
SUPPL37Null7
SUPPL38Null15

TE Codes

001PrescriptionAA

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20596
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPIVIR","activeIngredients":"LAMIVUDINE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/10\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020564s039,020596s038lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020564s039,020596s038lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2018","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020564s038,020596s037lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2017","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020564s37_020596s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2017","submission":"SUPPL-36","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020564s37_020596s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2016","submission":"SUPPL-35","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020564s036,020596s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2015","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020564s035,020596s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2015","submission":"SUPPL-34","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020564s035,020596s034lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2015","submission":"SUPPL-32","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020564s033,020596s032lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2015","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020564s034,020596s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020564s031,020596s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2006","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020596s027.pdf\"}]","notes":""},{"actionDate":"06\/13\/2006","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020596s025,020564s024lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2004","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20596s021,20564s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2004","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20596s022,20564s021lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2003","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20596slr020,20564slr019_epivir_lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2002","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20564s14,20596s15lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2002","submission":"SUPPL-16","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20564s015and20596s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EPIVIR","submission":"LAMIVUDINE","actionType":"10MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-10
        )

)
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