APOTEX CORP FDA Approval ANDA 065509

ANDA 065509

APOTEX CORP

FDA Drug Application

Application #065509

Application Sponsors

ANDA 065509APOTEX CORP

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 500MG BASE0AZITHROMYCINAZITHROMYCIN

FDA Submissions

ORIG1AP2011-07-13
LABELING; LabelingSUPPL2AP2015-11-05STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

CDER Filings

APOTEX CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65509
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.