ANDA 212945

AMNEAL EU LTD

FDA Drug Application

Application #212945

Documents

• Letter: 2022-09-08

Application Sponsors

ANDA 212945

AMNEAL EU LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

200UNITS/10ML(20UNITS/ML)

0

VASOPRESSIN

VASOPRESSIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AMNEAL EU LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212945
            [companyName] => AMNEAL EU LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VASOPRESSIN","activeIngredients":"VASOPRESSIN","strength":"200UNITS\/10ML(20UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-10
        )

)