NDA 215866

ELI LILLY CO

FDA Drug Application

Application #215866

Documents

• Label: 2022-05-13
• Letter: 2022-05-16
• Review: 2022-06-15

Application Sponsors

NDA 215866

ELI LILLY CO

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	INJECTABLE;INJECTION	2.5MG	0	MOUNJARO	TIRZEPATIDE
002	INJECTABLE;INJECTION	5MG	0	MOUNJARO	TIRZEPATIDE
003	INJECTABLE;INJECTION	7.5MG	0	MOUNJARO	TIRZEPATIDE
004	INJECTABLE;INJECTION	10MG	0	MOUNJARO	TIRZEPATIDE
005	INJECTABLE;INJECTION	12.5MG	0	MOUNJARO	TIRZEPATIDE
006	INJECTABLE;INJECTION	15MG	0	MOUNJARO	TIRZEPATIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-05-13

PRIORITY

Submissions Property Types

ORIG

1

Null

7

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
        )

)