ANDA 202079

APOTEX INC

FDA Drug Application

Application #202079

Application Sponsors

ANDA 202079

APOTEX INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	4MG	0	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL
002	TABLET;ORAL	8MG	0	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL
003	TABLET;ORAL	16MG	0	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL
004	TABLET;ORAL	32MG	0	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-01-10
LABELING; Labeling	SUPPL	2	AP	2016-02-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202079
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"32MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/10\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/12\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-02-12
        )

)