BLA 761143

HORIZON THERAPEUTICS IRELAND

FDA Drug Application

Application #761143

Documents

• Letter: 2020-01-22
• Label: 2020-01-22
• Review: 2020-03-02

Application Sponsors

BLA 761143

HORIZON THERAPEUTICS IRELAND

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG

2

TEPEZZA

TEPROTUMUMAB-TRBW

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-01-21

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

HORIZON THERAPEUTICS IRELAND

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            [companyName] => HORIZON THERAPEUTICS IRELAND
            [docInserts] => ["",""]
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            [labels] => [{"actionDate":"01\/21\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761143s000lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2020-01-21
        )

)