ELI LILLY AND CO FDA Approval BLA 761109

BLA 761109

ELI LILLY AND CO

FDA Drug Application

Application #761109

Documents

Label2020-06-15
Letter2020-06-17

Application Sponsors

BLA 761109ELI LILLY AND CO

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION100UNITS/ML(U-100)0LYUMJEVINSULIN LISPRO-AABC
002INJECTABLE;INJECTION200UNITS/ML(U-200)0LYUMJEVINSULIN LISPRO-AABC

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-06-15PRIORITY

Submissions Property Types

ORIG1Null15

CDER Filings

ELI LILLY AND CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761109
            [companyName] => ELI LILLY AND CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"LYUMJEV","activeIngredients":"INSULIN LISPRO-AABC","strength":"100UNITS\/ML(U-100)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LYUMJEV","activeIngredients":"INSULIN LISPRO-AABC","strength":"200UNITS\/ML(U-200)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/15\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761109s000lbl_replacement.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761109s000lbl_replacement.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761109Orig1s000ltr_replacement.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-15
        )

)

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