ANDA 214924

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #214924

Application Sponsors

ANDA 214924

MSN LABORATORIES PRIVATE LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;INTRAVENOUS

50MG/5ML (10MG/ML)

0

BRIVARACETAM

BRIVARACETAM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABORATORIES PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214924
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-14
        )

)