NDA 214018

ORIGIN BIOSCIENCES INC

FDA Drug Application

Application #214018

Documents

• Letter: 2021-03-01
• Label: 2021-02-26
• Review: 2021-03-26
• Letter: 2022-10-28
• Label: 2022-11-01

Application Sponsors

NDA 214018

ORIGIN BIOSCIENCES INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

9.5MG

2

NULIBRY

FOSDENOPTERIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-02-26	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-10-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6

CDER Filings

ORIGIN BIOSCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214018
            [companyName] => ORIGIN BIOSCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NULIBRY","activeIngredients":"FOSDENOPTERIN","strength":"9.5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214018Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-26
        )

)