HIKMA INTL PHARMS FDA Approval ANDA 040510

ANDA 040510

HIKMA INTL PHARMS

FDA Drug Application

Application #040510

Application Sponsors

ANDA 040510HIKMA INTL PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL100MG;1MG0ERGOTAMINE TARTRATE AND CAFFEINECAFFEINE; ERGOTAMINE TARTRATE

FDA Submissions

ORIG1AP2004-09-17

TE Codes

001PrescriptionAA

CDER Filings

HIKMA INTL PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40510
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERGOTAMINE TARTRATE AND CAFFEINE","activeIngredients":"CAFFEINE; ERGOTAMINE TARTRATE","strength":"100MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERGOTAMINE TARTRATE AND CAFFEINE","submission":"CAFFEINE; ERGOTAMINE TARTRATE","actionType":"100MG;1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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