NDA 022231

MALLINCKRODT

FDA Drug Application

Application #022231

Documents

• Label: 2022-09-14
• Letter: 2022-09-15
• Review: 2022-10-07
• Label: 2023-01-10
• Letter: 2023-01-10

Application Sponsors

NDA 022231

MALLINCKRODT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.85MG

0

TERLIVAZ

TERLIPRESSIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-09-14

PRIORITY

Submissions Property Types

ORIG

1

Null

6

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
        )

)