BLA 761142

VIELA BIO

FDA Drug Application

Application #761142

Documents

• Letter: 2020-06-12
• Label: 2020-06-12
• Medication Guide: 2020-06-12
• Review: 2020-07-06

Application Sponsors

BLA 761142

VIELA BIO

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/10ML

0

UPLIZNA

INEBILIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-06-11

STANDARD

Submissions Property Types

ORIG

1

Null

30

CDER Filings

VIELA BIO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761142
            [companyName] => VIELA BIO
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761142s000lbl.pdf#page=17"]
            [products] => [{"drugName":"UPLIZNA","activeIngredients":"INEBILIZUMAB","strength":"100MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/11\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761142s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761142s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761142Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-11
        )

)