BLA 761092

LEADIANT BIOSCI INC

FDA Drug Application

Application #761092

Documents

• Label: 2018-10-05
• Letter: 2018-10-15
• Review: 2018-11-07
• Label: 2020-12-07
• Letter: 2020-12-08

Application Sponsors

BLA 761092

LEADIANT BIOSCI INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1.6MG/ML

0

REVCOVI

ELAPEGADEMASE-LVLR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-10-05	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2020-12-05	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	5	Null	6

CDER Filings

LEADIANT BIOSCI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761092
            [companyName] => LEADIANT BIOSCI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REVCOVI","activeIngredients":"ELAPEGADEMASE-LVLR","strength":"1.6MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/05\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761092s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761092s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761092Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761092Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-10-05
        )

)