GLAXOSMITHKLINE FDA Approval BLA 761122

BLA 761122

GLAXOSMITHKLINE

FDA Drug Application

Application #761122

Documents

Label2019-06-07
Letter2019-06-07
Review2019-08-26
Letter2019-09-13
Letter2019-09-13
Label2019-09-13
Label2019-09-13
Pediatric Other1900-01-01

Application Sponsors

BLA 761122GLAXOSMITHKLINE

Marketing Status

Prescription001

Application Products

001INJECTABLE;SUBCUTANEOUS100MG/ML0NUCALAMEPOLIZUMAB

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2019-06-06STANDARD
LABELING; LabelingSUPPL2AP2019-09-12STANDARD
EFFICACY; EfficacySUPPL3AP2019-09-12STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null15
SUPPL3Null6

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761122
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUCALA","activeIngredients":"MEPOLIZUMAB","strength":"100MG\/ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/12\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761122s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761122s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761122Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761122Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/12\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125526Orig1s012,%20761122Orig1s002,s003ltr.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2019","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125526Orig1s012,%20761122Orig1s002,s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-09-12
        )

)

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