VIIV HLTHCARE FDA Approval NDA 019910

NDA 019910

VIIV HLTHCARE

FDA Drug Application

Application #019910

Documents

Letter2003-10-17
Letter2006-05-18
Letter2008-09-23
Letter2010-01-07
Letter2010-05-21
Letter2012-06-04
Letter2014-12-31
Label2003-06-10
Label2003-10-17
Label2006-05-16
Label2006-11-16
Label2009-11-19
Label2010-05-18
Letter2001-03-30
Letter2002-02-21
Letter2002-12-18
Letter2006-11-22
Letter2011-12-01
Review2005-04-19
Label2001-03-30
Label2003-04-04
Label2008-09-23
Label2011-11-25
Label2012-06-06
Label2015-01-08
Label2017-02-28
Letter2017-03-03
Label2017-04-13
Letter2017-04-14
Label2017-11-29
Letter2017-12-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2018-09-11
Letter2018-09-12
Letter2020-06-19
Label2021-01-19
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Medical Review1900-01-01

Application Sponsors

NDA 019910VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001SYRUP;ORAL50MG/5ML1RETROVIRZIDOVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1989-09-28PRIORITY
EFFICACY; EfficacySUPPL2AP1990-05-02
EFFICACY; EfficacySUPPL3AP1990-01-12
EFFICACY; EfficacySUPPL4AP1990-03-02
LABELING; LabelingSUPPL7AP1994-08-08
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1992-10-19
LABELING; LabelingSUPPL10AP1993-08-24STANDARD
EFFICACY; EfficacySUPPL11AP1994-08-08PRIORITY
LABELING; LabelingSUPPL12AP1994-10-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1995-02-06
EFFICACY; EfficacySUPPL15AP1996-10-04UNKNOWN
LABELING; LabelingSUPPL16AP1995-07-20STANDARD
EFFICACY; EfficacySUPPL18AP1996-10-04STANDARD
LABELING; LabelingSUPPL19AP1998-03-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1998-02-25
LABELING; LabelingSUPPL21AP2001-03-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1999-02-26
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2000-02-01
LABELING; LabelingSUPPL24AP2001-10-05STANDARD
LABELING; LabelingSUPPL25AP2002-02-21STANDARD
LABELING; LabelingSUPPL26AP2002-12-18STANDARD
LABELING; LabelingSUPPL27AP2003-10-15STANDARD
LABELING; LabelingSUPPL29AP2006-05-10STANDARD
LABELING; LabelingSUPPL32AP2006-11-15STANDARD
EFFICACY; EfficacySUPPL33AP2008-09-19PRIORITY
EFFICACY; EfficacySUPPL35AP2009-11-06PRIORITY
LABELING; LabelingSUPPL36AP2010-05-17STANDARD
LABELING; LabelingSUPPL39AP2011-11-18901 REQUIRED
LABELING; LabelingSUPPL40AP2012-05-31STANDARD
LABELING; LabelingSUPPL41AP2014-12-23STANDARD
LABELING; LabelingSUPPL42AP2017-02-24STANDARD
LABELING; LabelingSUPPL43AP2017-04-10STANDARD
LABELING; LabelingSUPPL44AP2017-11-28STANDARD
LABELING; LabelingSUPPL45AP2018-09-10STANDARD
LABELING; LabelingSUPPL46AP2019-12-20STANDARD

Submissions Property Types

ORIG1Null39
SUPPL8Null0
SUPPL13Null0
SUPPL20Null0
SUPPL22Null0
SUPPL23Null0
SUPPL33Null6
SUPPL35Null7
SUPPL36Null6
SUPPL39Null7
SUPPL40Null7
SUPPL41Null15
SUPPL42Null6
SUPPL43Null6
SUPPL44Null7
SUPPL45Null7
SUPPL46Null15

TE Codes

001PrescriptionAA

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19910
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RETROVIR","activeIngredients":"ZIDOVUDINE","strength":"50MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/10\/2018","submission":"SUPPL-45","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-45","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-44","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-43","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-42","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-41","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-40","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-39","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-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019910s036lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-35","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019910s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2008","submission":"SUPPL-33","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019910s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2006","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019910s032lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2006","submission":"SUPPL-29","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-27","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-26","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-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19910s24lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2001","submission":"SUPPL-21","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":"50MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-09-10
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.