ANDA 214925

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #214925

Documents

• Letter: 2022-08-01

Application Sponsors

ANDA 214925

MSN LABORATORIES PRIVATE LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE; ORAL

34MG

0

PIMAVANSERIN

PIMAVANSERIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABORATORIES PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214925
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIMAVANSERIN","activeIngredients":"PIMAVANSERIN","strength":"34mg","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-03
        )

)