VIIV HLTHCARE FDA Approval NDA 019655

NDA 019655

VIIV HLTHCARE

FDA Drug Application

Application #019655

Documents

Letter2001-03-30
Letter2002-02-21
Letter2010-05-21
Letter2011-12-01
Label2003-06-16
Label2006-05-16
Label2008-09-25
Label2010-05-18
Label2011-11-25
Letter2002-12-18
Letter2003-10-17
Letter2006-05-18
Letter2006-11-22
Letter2008-09-23
Letter2010-01-06
Letter2012-06-04
Letter2014-12-31
Label2001-03-30
Label2003-04-04
Label2003-10-17
Label2006-11-16
Label2009-11-23
Label2012-06-06
Label2015-01-08
Review2005-04-19
Label2017-02-28
Letter2017-03-03
Label2017-04-13
Letter2017-04-14
Label2017-11-29
Letter2017-12-01
Label2018-09-11
Letter2018-09-12
Letter2020-06-19
Label2021-01-19

Application Sponsors

NDA 019655VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG1RETROVIRZIDOVUDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1987-03-19PRIORITY
LABELING; LabelingSUPPL3AP1993-08-24
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1988-10-13
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1989-03-06
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1989-03-13
LABELING; LabelingSUPPL11AP1990-03-02
LABELING; LabelingSUPPL12AP1993-08-24
EFFICACY; EfficacySUPPL13AP1990-01-12
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1990-04-30
LABELING; LabelingSUPPL15AP1990-05-02
LABELING; LabelingSUPPL20AP1994-08-08
LABELING; LabelingSUPPL22AP1993-08-24STANDARD
EFFICACY; EfficacySUPPL23AP1994-08-08PRIORITY
LABELING; LabelingSUPPL24AP1994-10-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1995-02-06
EFFICACY; EfficacySUPPL26AP1996-10-04UNKNOWN
LABELING; LabelingSUPPL27AP1995-07-20STANDARD
EFFICACY; EfficacySUPPL29AP1996-10-04STANDARD
LABELING; LabelingSUPPL30AP1998-03-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL31AP1997-11-04
LABELING; LabelingSUPPL32AP2001-03-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP1998-12-28
MANUF (CMC); Manufacturing (CMC)SUPPL34AP1999-02-26
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2000-02-01
LABELING; LabelingSUPPL36AP2001-10-05STANDARD
LABELING; LabelingSUPPL37AP2002-02-21STANDARD
LABELING; LabelingSUPPL38AP2002-12-18STANDARD
LABELING; LabelingSUPPL39AP2003-10-15STANDARD
LABELING; LabelingSUPPL41AP2006-05-10STANDARD
LABELING; LabelingSUPPL43AP2006-11-15STANDARD
EFFICACY; EfficacySUPPL46AP2008-09-19UNKNOWN
LABELING; LabelingSUPPL48AP2009-11-06STANDARD
LABELING; LabelingSUPPL49AP2010-05-17STANDARD
LABELING; LabelingSUPPL52AP2011-11-18901 REQUIRED
LABELING; LabelingSUPPL53AP2012-05-31STANDARD
LABELING; LabelingSUPPL54AP2014-12-23STANDARD
LABELING; LabelingSUPPL55AP2017-02-24STANDARD
LABELING; LabelingSUPPL56AP2017-04-10STANDARD
LABELING; LabelingSUPPL57AP2017-11-28STANDARD
LABELING; LabelingSUPPL58AP2018-09-10STANDARD
LABELING; LabelingSUPPL59AP2019-12-20STANDARD

Submissions Property Types

ORIG1Orphan5
SUPPL5Null14
SUPPL8Null14
SUPPL9Null14
SUPPL14Null14
SUPPL25Null14
SUPPL31Null14
SUPPL33Null14
SUPPL34Null14
SUPPL35Null14
SUPPL46Null6
SUPPL48Null7
SUPPL49Null6
SUPPL52Null7
SUPPL53Null7
SUPPL54Null15
SUPPL55Null6
SUPPL56Null6
SUPPL57Null7
SUPPL58Null7
SUPPL59Null15

TE Codes

001PrescriptionAB

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19655
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RETROVIR","activeIngredients":"ZIDOVUDINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/10\/2018","submission":"SUPPL-58","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019655s058,019910s045,019951s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2018","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019655s058,019910s045,019951s036lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2017","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019655s057,019910s044,019951s035lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2017","submission":"SUPPL-56","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019655s056,019910s043,019951s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2017","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019655s056,019910s043,019951s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2017","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019655s055,019910s042,019951s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2014","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019910s041lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2012","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019655s053,019910s040,020518s023lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019655s052,019910s039,020518s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2010","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019655s049lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019655s048,020518s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2008","submission":"SUPPL-46","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019910s033,019655s046,020518s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2006","submission":"SUPPL-43","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019655s043lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2006","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019655s41,019910s29,020518s13lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2003","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2002","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2001","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19655s36lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2001","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20518S4lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RETROVIR","submission":"ZIDOVUDINE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-09-10
        )

)
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