GENENTECH INC FDA Approval NDA 213535

NDA 213535

GENENTECH INC

FDA Drug Application

Application #213535

Documents

Letter2020-08-03
Label2020-08-10
Review2020-09-04

Application Sponsors

NDA 213535GENENTECH INC

Marketing Status

Prescription001

Application Products

001POWDER FOR ORAL SOLUTION1.5MG0EVRYSDIRISDIPLAM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-08-07PRIORITY

Submissions Property Types

ORIG1Null10

CDER Filings

GENENTECH INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213535
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVRYSDI","activeIngredients":"RISDIPLAM","strength":"1.5MG","dosageForm":"POWDER FOR ORAL SOLUTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/07\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213535s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213535s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213535Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-07
        )

)

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