MIKART FDA Approval ANDA 040590

ANDA 040590

MIKART

FDA Drug Application

Application #040590

Application Sponsors

ANDA 040590MIKART

Marketing Status

Prescription001

Application Products

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

FDA Submissions

ORIG1AP2005-09-16

TE Codes

001PrescriptionAA

CDER Filings

MIKART
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40590
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERGOTAMINE TARTRATE AND CAFFEINE","activeIngredients":"CAFFEINE; ERGOTAMINE TARTRATE","strength":"100MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERGOTAMINE TARTRATE AND CAFFEINE","submission":"CAFFEINE; ERGOTAMINE TARTRATE","actionType":"100MG;1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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