ELI LILLY CO FDA Approval BLA 761215

BLA 761215

ELI LILLY CO

FDA Drug Application

Application #761215

Documents

Label2021-12-19
Letter2021-12-21

Application Sponsors

BLA 761215ELI LILLY CO

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION3ML(100UNITS/ML)0REZVOGLARINSULIN GLARGINE-AGLR

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2021-12-17STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

ELI LILLY CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761215
            [companyName] => ELI LILLY CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"REZVOGLAR","activeIngredients":"INSULIN GLARGINE-AGLR","strength":"3ML(100UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761215s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761215s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761215Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)

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