MALLINCKRODT FDA Approval NDA 022231

NDA 022231

MALLINCKRODT

FDA Drug Application

Application #022231

Documents

Label2022-09-14
Letter2022-09-15

Application Sponsors

NDA 022231MALLINCKRODT

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.85MG0TERLIVAZTERLIPRESSIN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-09-14PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

MALLINCKRODT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22231
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERLIVAZ","activeIngredients":"TERLIPRESSIN","strength":"0.85MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/14\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022231s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TERLIVAZ","submission":"TERLIPRESSIN","actionType":"0.85MG","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2022-09-14
        )

)

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