BIOCRYST PHARMACEUTICALS INC FDA Approval NDA 214094

NDA 214094

BIOCRYST PHARMACEUTICALS INC

FDA Drug Application

Application #214094

Documents

Letter2020-12-07
Label2020-12-10
Review2020-12-30

Application Sponsors

NDA 214094BIOCRYST PHARMACEUTICALS INC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE; ORAL150MG2ORLADEYOBEROTRALSTAT
002CAPSULE; ORAL110MG2ORLADEYOBEROTRALSTAT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-12-03STANDARD

Submissions Property Types

ORIG1Null2

TE Codes

001PrescriptionTBD
002PrescriptionTBD

CDER Filings

BIOCRYST PHARMACEUTICALS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214094
            [companyName] => BIOCRYST PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORLADEYO","activeIngredients":"BEROTRALSTAT","strength":"150MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ORLADEYO","activeIngredients":"BEROTRALSTAT","strength":"110MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214094Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-03
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.