BLA 761038

ELI LILLY AND CO

FDA Drug Application

Application #761038

Documents

• Label: 2016-10-19
• Letter: 2016-10-20
• Review: 2016-11-29
• Review: 2019-08-07

Application Sponsors

BLA 761038

ELI LILLY AND CO

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

500MG/50ML

0

LARTRUVO

OLARATUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2016-10-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2018-08-09	N/A

Submissions Property Types

ORIG	1	Null	30
SUPPL	9	Null	15

CDER Filings

ELI LILLY AND CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761038
            [companyName] => ELI LILLY AND CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"LARTRUVO","activeIngredients":"OLARATUMAB","strength":"500MG\/50ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/19\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761038lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761038lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761038Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761038Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/09\/2018","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/10\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761038Orig1s001.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-10
        )

)