APOTEX CORP FDA Approval ANDA 200164

ANDA 200164

APOTEX CORP

FDA Drug Application

Application #200164

Application Sponsors

ANDA 200164APOTEX CORP

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL1MG0TOLTERODINE TARTRATETOLTERODINE TARTRATE
002TABLET;ORAL2MG0TOLTERODINE TARTRATETOLTERODINE TARTRATE

FDA Submissions

N/A; Not ApplicableORIG1AP2012-09-25

Submissions Property Types

ORIG1Null7

CDER Filings

APOTEX CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200164
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/25\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-09-25
        )

)

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