GLAXOSMITHKLINE FDA Approval BLA 761158

BLA 761158

GLAXOSMITHKLINE

FDA Drug Application

Application #761158

Documents

Label2020-08-06
Medication Guide2020-08-06
Letter2020-08-10
Review2020-09-01

Application Sponsors

BLA 761158GLAXOSMITHKLINE

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS2.5MG/KG0BLENREPBELANTAMAB MAFODOTIN-BLMF

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-08-05PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761158
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761158s000lbl.pdf#page=21"]
            [products] => [{"drugName":"BLENREP","activeIngredients":"BELANTAMAB MAFODOTIN-BLMF","strength":"2.5MG\/KG","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/05\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761158s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761158s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761158Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-05
        )

)

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