BLA 761183

PROVENTION BIO INC

FDA Drug Application

Application #761183

Documents

• Label: 2022-11-21
• Letter: 2022-11-22
• Medication Guide: 2022-12-15
• Review: 2023-01-05

Application Sponsors

BLA 761183

PROVENTION BIO INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MG/2ML(1MG/ML)

0

TZIELD

TEPLIZUMAB-MZWV

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-11-17

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

PROVENTION BIO INC

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(
    [0] => Array
        (
            [ApplNo] => 761183
            [companyName] => PROVENTION BIO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TZIELD","activeIngredients":"TEPLIZUMAB-MZWV","strength":"2MG\/2ML(1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/17\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761183s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761183s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761183Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-11-17
        )

)