BLA 761215

ELI LILLY CO

FDA Drug Application

Application #761215

Documents

• Label: 2021-12-19
• Letter: 2021-12-21
• Review: 2022-01-28
• Label: 2022-11-16
• Letter: 2022-11-17
• Review: 2022-12-22

Application Sponsors

BLA 761215

ELI LILLY CO

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

3ML(100UNITS/ML)

0

REZVOGLAR

INSULIN GLARGINE-AGLR

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2021-12-17	STANDARD
TYPE 2; Type 2 - New Active Ingredient	ORIG	2	AP	2022-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	6

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
        )

)