VIIV HLTHCARE FDA Approval NDA 020857

NDA 020857

VIIV HLTHCARE

FDA Drug Application

Application #020857

Documents

Letter2002-08-09
Letter2004-05-26
Letter2004-10-04
Letter2006-07-03
Letter2009-02-04
Letter2010-10-04
Letter2011-11-22
Label2002-08-09
Label2006-06-28
Label2006-10-26
Label2007-04-25
Label2009-02-04
Label2011-12-02
Label2015-09-29
Review2005-01-11
Review2007-09-24
Review2007-09-24
Letter2002-08-09
Letter2002-10-08
Letter2006-11-06
Letter2007-05-01
Letter2015-09-28
Label2002-08-09
Label2002-10-08
Label2004-05-27
Label2004-10-04
Label2010-10-12
Review2007-09-24
Label2017-02-28
Letter2017-03-03
Label2017-04-11
Letter2017-04-14
Letter2018-05-01
Label2018-05-14
Letter2019-05-14
Label2019-05-15

Application Sponsors

NDA 020857VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET;ORAL150MG;300MG1COMBIVIRLAMIVUDINE; ZIDOVUDINE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP1997-09-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-07-31PRIORITY
LABELING; LabelingSUPPL3AP1999-03-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-02-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-04-12PRIORITY
LABELING; LabelingSUPPL6AP2000-01-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-02-01PRIORITY
LABELING; LabelingSUPPL8AP2000-09-29STANDARD
LABELING; LabelingSUPPL9AP2002-08-09STANDARD
LABELING; LabelingSUPPL10AP2002-08-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2002-09-13PRIORITY
LABELING; LabelingSUPPL12AP2002-10-08STANDARD
LABELING; LabelingSUPPL14AP2004-05-17STANDARD
LABELING; LabelingSUPPL15AP2004-09-29STANDARD
LABELING; LabelingSUPPL18AP2006-06-27STANDARD
LABELING; LabelingSUPPL20AP2006-10-25STANDARD
LABELING; LabelingSUPPL21AP2007-04-23STANDARD
EFFICACY; EfficacySUPPL23AP2009-02-02PRIORITY
LABELING; LabelingSUPPL26AP2010-10-01UNKNOWN
LABELING; LabelingSUPPL28AP2011-11-18901 REQUIRED
LABELING; LabelingSUPPL30AP2015-09-25STANDARD
LABELING; LabelingSUPPL31AP2017-02-24STANDARD
LABELING; LabelingSUPPL32AP2017-04-10STANDARD
LABELING; LabelingSUPPL33AP2018-04-27STANDARD
LABELING; LabelingSUPPL34AP2019-05-10STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL11Null0
SUPPL23Null6
SUPPL26Null6
SUPPL28Null15
SUPPL30Null7
SUPPL31Null33
SUPPL32Null6
SUPPL33Null6
SUPPL34Null6

TE Codes

001PrescriptionAB

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20857
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"COMBIVIR","activeIngredients":"LAMIVUDINE; ZIDOVUDINE","strength":"150MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/10\/2019","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020857s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020857s033lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2017","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020857s032lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2017","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020857s031lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2015","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/20857s030lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020857s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2010","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020857s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2009","submission":"SUPPL-23","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020857s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2007","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020857s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2006","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020857s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2006","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020857s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2004","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20857s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2004","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20857slr014_combivir_lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2002","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20857s12lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2002","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20857slr012lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2002","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20857slr012lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COMBIVIR","submission":"LAMIVUDINE; ZIDOVUDINE","actionType":"150MG;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-10
        )

)
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