APOTEX CORP FDA Approval ANDA 065508

ANDA 065508

APOTEX CORP

FDA Drug Application

Application #065508

Application Sponsors

ANDA 065508APOTEX CORP

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 600MG BASE0AZITHROMYCINAZITHROMYCIN

FDA Submissions

ORIG1AP2011-07-13
LABELING; LabelingSUPPL2AP2015-03-20STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15

CDER Filings

APOTEX CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65508
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 600MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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