APOTEX INC FDA Approval ANDA 202476

ANDA 202476

APOTEX INC

FDA Drug Application

Application #202476

Application Sponsors

ANDA 202476APOTEX INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET, ORALLY DISINTEGRATING;ORAL2.5MG0ZOLMITRIPTANZOLMITRIPTAN
002TABLET, ORALLY DISINTEGRATING;ORAL5MG0ZOLMITRIPTANZOLMITRIPTAN

FDA Submissions

UNKNOWN; ORIG1AP2013-05-14

Submissions Property Types

ORIG1Null7

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202476
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-05-14
        )

)

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