ELI LILLY CO FDA Approval NDA 215866

NDA 215866

ELI LILLY CO

FDA Drug Application

Application #215866

Documents

Label2022-05-13
Letter2022-05-16
Review2022-06-15

Application Sponsors

NDA 215866ELI LILLY CO

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001INJECTABLE;INJECTION2.5MG0MOUNJAROTIRZEPATIDE
002INJECTABLE;INJECTION5MG0MOUNJAROTIRZEPATIDE
003INJECTABLE;INJECTION7.5MG0MOUNJAROTIRZEPATIDE
004INJECTABLE;INJECTION10MG0MOUNJAROTIRZEPATIDE
005INJECTABLE;INJECTION12.5MG0MOUNJAROTIRZEPATIDE
006INJECTABLE;INJECTION15MG0MOUNJAROTIRZEPATIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-05-13PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

ELI LILLY CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215866
            [companyName] => ELI LILLY CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOUNJARO","activeIngredients":"TIRZEPATIDE","strength":"2.5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MOUNJARO","activeIngredients":"TIRZEPATIDE","strength":"5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MOUNJARO","activeIngredients":"TIRZEPATIDE","strength":"7.5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MOUNJARO","activeIngredients":"TIRZEPATIDE","strength":"10MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MOUNJARO","activeIngredients":"TIRZEPATIDE","strength":"12.5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MOUNJARO","activeIngredients":"TIRZEPATIDE","strength":"15MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/13\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215866s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215866s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215866Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-05-13
        )

)

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