GLAXOSMITHKLINE FDA Approval NDA 203975

NDA 203975

GLAXOSMITHKLINE

FDA Drug Application

Application #203975

Documents

Letter2016-02-26
Summary Review2014-01-06
Letter2013-12-20
Label2013-12-19
Label2016-02-26
Review2014-01-06
Label2017-03-23
Medication Guide2017-03-23
Letter2017-03-24
Label2017-10-19
Letter2017-10-19
Label2019-05-30
Letter2019-06-04
Label2019-06-25
Letter2019-06-26
Letter2022-10-21
Label2022-10-21

Application Sponsors

NDA 203975GLAXOSMITHKLINE

Marketing Status

Prescription001

Application Products

001POWDER;INHALATIONEQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH1ANORO ELLIPTAUMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2013-12-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2015-08-27STANDARD
LABELING; LabelingSUPPL3AP2016-02-24STANDARD
LABELING; LabelingSUPPL5AP2017-03-22STANDARD
LABELING; LabelingSUPPL7AP2017-10-17STANDARD
LABELING; LabelingSUPPL9AP2019-05-29STANDARD
EFFICACY; EfficacySUPPL10AP2019-06-06STANDARD
LABELING; LabelingSUPPL13AP2022-10-20STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null0
SUPPL3Null15
SUPPL5Null7
SUPPL7Null7
SUPPL9Null7
SUPPL10Null7
SUPPL13Null6

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203975
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANORO ELLIPTA","activeIngredients":"UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE","strength":"EQ 0.0625MG BASE\/INH;EQ 0.025MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/06\/2019","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203975Orig1s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203975s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203975s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203975s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203975s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203975s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203975s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203975s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/18\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203975s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203975Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203975Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203975Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/06\/2019","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203975Orig1s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203975Orig1s010_REPLACEMENTltr.pdf\"}]","notes":">"},{"actionDate":"05\/29\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203975s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203975Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/17\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203975s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203975Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203975s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203975Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"02\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203975s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203975Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"08\/27\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/07\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-06
        )

)
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