EPIC PHARMA LLC FDA Approval ANDA 040714

ANDA 040714

EPIC PHARMA LLC

FDA Drug Application

Application #040714

Application Sponsors

ANDA 040714EPIC PHARMA LLC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL50MG0BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2007-10-29
LABELING; LabelingSUPPL2AP2009-08-31

Submissions Property Types

SUPPL2Null7

CDER Filings

EPIC PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40714
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZPHETAMINE HYDROCHLORIDE","activeIngredients":"BENZPHETAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZPHETAMINE HYDROCHLORIDE","submission":"BENZPHETAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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