ELITE LABS INC FDA Approval ANDA 040762

ANDA 040762

ELITE LABS INC

FDA Drug Application

Application #040762

Application Sponsors

ANDA 040762ELITE LABS INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL35MG0PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE

FDA Submissions

ORIG1AP2008-01-28

TE Codes

001PrescriptionAA

CDER Filings

ELITE LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40762
            [companyName] => ELITE LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENDIMETRAZINE TARTRATE","activeIngredients":"PHENDIMETRAZINE TARTRATE","strength":"35MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENDIMETRAZINE TARTRATE","submission":"PHENDIMETRAZINE TARTRATE","actionType":"35MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.