ANDA 214782

AUROBINDO PHARMA LTD

FDA Drug Application

Application #214782

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 214782

AUROBINDO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

34MG

0

PIMAVANSERIN

PIMAVANSERIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214782
            [companyName] => AUROBINDO PHARMA 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":"11\/07\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-07
        )

)