VIIV HLTHCARE FDA Approval NDA 021652

NDA 021652

VIIV HLTHCARE

FDA Drug Application

Application #021652

Documents

Letter2006-08-18
Letter2009-03-11
Letter2011-02-07
Letter2010-08-10
Letter2011-05-17
Letter2011-11-22
Letter2012-03-13
Letter2012-05-22
Letter2015-09-18
Letter2015-10-01
Label2006-08-14
Label2012-03-12
Label2015-10-07
Letter2004-08-05
Letter2007-05-09
Letter2015-02-24
Label2004-08-05
Label2007-05-09
Label2009-03-26
Label2011-02-04
Label2011-11-29
Label2012-05-22
Label2015-02-20
Review2006-10-25
Label2017-03-21
Letter2017-03-24
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2018-05-01
Label2018-05-08
Medication Guide2018-05-08
Label2019-05-14
Letter2019-05-15
Label2021-02-18
Medication Guide2021-02-18
Letter2021-02-18
Label2021-12-15
Medication Guide2021-12-15
Letter2021-12-15

Application Sponsors

NDA 021652VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 600MG BASE;300MG1EPZICOMABACAVIR SULFATE; LAMIVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2004-08-02STANDARD
LABELING; LabelingSUPPL3AP2006-08-11STANDARD
LABELING; LabelingSUPPL5AP2007-05-07STANDARD
LABELING; LabelingSUPPL8AP2009-03-09STANDARD
LABELING; LabelingSUPPL10AP2011-02-02STANDARD
REMS; REMSSUPPL11AP2010-08-04N/A
REMS; REMSSUPPL13AP2011-05-13N/A
LABELING; LabelingSUPPL14AP2011-11-18901 REQUIRED
LABELING; LabelingSUPPL15AP2012-03-12STANDARD
LABELING; LabelingSUPPL16AP2012-05-18STANDARD
LABELING; LabelingSUPPL18AP2015-02-19STANDARD
EFFICACY; EfficacySUPPL19AP2015-09-17STANDARD
LABELING; LabelingSUPPL21AP2015-09-29STANDARD
LABELING; LabelingSUPPL22AP2017-03-20STANDARD
LABELING; LabelingSUPPL23AP2018-04-27STANDARD
LABELING; LabelingSUPPL24AP2019-05-10STANDARD
LABELING; LabelingSUPPL28AP2021-02-17STANDARD
EFFICACY; EfficacySUPPL29AP2021-12-10STANDARD

Submissions Property Types

SUPPL8Null7
SUPPL10Null7
SUPPL11Null6
SUPPL13Null7
SUPPL14Null15
SUPPL15Null6
SUPPL16Null6
SUPPL18Null7
SUPPL19Null7
SUPPL21Null7
SUPPL22Null7
SUPPL23Null31
SUPPL24Null15
SUPPL28Null6
SUPPL29Null6

TE Codes

001PrescriptionAB

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21652
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/021652s028lbl.pdf#page=27"]
            [products] => [{"drugName":"EPZICOM","activeIngredients":"ABACAVIR SULFATE; LAMIVUDINE","strength":"EQ 600MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/17\/2021","submission":"SUPPL-28","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021652s028lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2021","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021652s028lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021652s024lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021652s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021652s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021652s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021652s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021652s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2015","submission":"SUPPL-21","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021652s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2015","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021652s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021652s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2012","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021652s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2012","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021652s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021652s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2011","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021652s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2009","submission":"SUPPL-8","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021652s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2009","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021652s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2009","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021652s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2007","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021652s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2006","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021652s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21652lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EPZICOM","submission":"ABACAVIR SULFATE; LAMIVUDINE","actionType":"EQ 600MG BASE;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-02-17
        )

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