ANDA 065509

APOTEX CORP

FDA Drug Application

Application #065509

Application Sponsors

ANDA 065509

APOTEX CORP

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 500MG BASE

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

	ORIG	1	AP	2011-07-13
LABELING; Labeling	SUPPL	2	AP	2015-11-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

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
        )

)