GLAXOSMITHKLINE FDA Approval NDA 021036

NDA 021036

GLAXOSMITHKLINE

FDA Drug Application

Application #021036

Documents

Letter1999-07-26
Letter2009-10-16
Letter2007-03-15
Letter2009-10-16
Letter2008-02-25
Letter2008-10-07
Letter2010-05-07
Letter2010-12-15
Label1999-07-26
Label2001-04-27
Label2006-04-03
Label2007-09-11
Label2011-12-23
Review1999-07-26
Review2004-04-12
Review2014-01-16
Letter2000-04-26
Letter2004-06-15
Letter2003-08-15
Letter2009-10-16
Letter2006-04-05
Letter2007-09-11
Letter2009-10-16
Letter2009-10-16
Letter2010-03-29
Letter2011-12-22
Label2000-04-26
Label2003-10-07
Label2003-08-15
Label2008-02-25
Label2008-10-09
Label2010-03-26
Label2010-12-10
Label2018-06-27
Letter2018-06-27
Label2021-10-20
Letter2021-10-21

Application Sponsors

NDA 021036GLAXOSMITHKLINE

Marketing Status

Prescription001

Application Products

001POWDER;INHALATION5MG1RELENZAZANAMIVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1999-07-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2001-05-18PRIORITY
LABELING; LabelingSUPPL4AP2001-04-27STANDARD
LABELING; LabelingSUPPL5AP2003-08-05STANDARD
LABELING; LabelingSUPPL6AP2003-08-06STANDARD
LABELING; LabelingSUPPL7AP2004-03-25PRIORITY
EFFICACY; EfficacySUPPL8AP2006-03-29PRIORITY
EFFICACY; EfficacySUPPL9AP2006-03-29PRIORITY
LABELING; LabelingSUPPL10AP2006-11-22PRIORITY
LABELING; LabelingSUPPL12AP2007-09-07STANDARD
LABELING; LabelingSUPPL13AP2007-03-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2007-06-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2007-12-13PRIORITY
LABELING; LabelingSUPPL16AP2008-02-21STANDARD
LABELING; LabelingSUPPL17AP2008-10-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2009-05-08PRIORITY
LABELING; LabelingSUPPL19AP2010-03-24UNKNOWN
LABELING; LabelingSUPPL24AP2010-05-04UNKNOWN
LABELING; LabelingSUPPL25AP2010-12-09STANDARD
LABELING; LabelingSUPPL27AP2011-12-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2013-02-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2016-07-21PRIORITY
LABELING; LabelingSUPPL30AP2018-06-21STANDARD
LABELING; LabelingSUPPL32AP2021-10-19STANDARD

Submissions Property Types

SUPPL3Null0
SUPPL7Null0
SUPPL10Null0
SUPPL14Null0
SUPPL15Null0
SUPPL18Null0
SUPPL19Null6
SUPPL24Null7
SUPPL25Null6
SUPPL27Null15
SUPPL28Null0
SUPPL29Null0
SUPPL30Null15
SUPPL32Null7

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21036
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RELENZA","activeIngredients":"ZANAMIVIR","strength":"5MG","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/21\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021036s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021036s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2011","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021036s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/09\/2010","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021036s025lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2010","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021036s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2008","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021036s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021036s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2007","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021036s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2006","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021036s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2003","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21036slr006_relenza_lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2003","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021036s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2001","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21036S4lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2000","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21036S1LBL.PDF\"}]","notes":""},{"actionDate":"07\/26\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/21036lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RELENZA","submission":"ZANAMIVIR","actionType":"5MG","submissionClassification":"POWDER;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-06-21
        )

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