ANDA 212944

AMNEAL

FDA Drug Application

Application #212944

Application Sponsors

ANDA 212944

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

20UNTS/ML (20UNITS/ML)

0

VASOPRESSIN

VASOPRESSIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212944
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"VASOPRESSIN","activeIngredients":"VASOPRESSIN","strength":"20UNTS\/ML (20UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-05
        )

)