ANDA 200654

APOTEX INC

FDA Drug Application

Application #200654

Application Sponsors

ANDA 200654

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

1MG

0

ANASTROZOLE

ANASTROZOLE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-05-11
LABELING; Labeling	SUPPL	2	AP	2016-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200654
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANASTROZOLE","activeIngredients":"ANASTROZOLE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/12\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/12\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-01-12
        )

)