ANDA 202884

APOTEX INC

FDA Drug Application

Application #202884

Documents

• Letter: 2012-12-06

Application Sponsors

ANDA 202884

APOTEX INC

Marketing Status

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

Application Products

001	TABLET;ORAL	16MG;12.5MG	0	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	32MG;12.5MG	0	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
003	TABLET;ORAL	32MG;25MG	0	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2012-12-04
UNKNOWN;	ORIG	2	AP	2013-06-03
LABELING; Labeling	SUPPL	4	AP	2016-02-12	STANDARD

Submissions Property Types

ORIG	1	Null	19
ORIG	2	Null	15
SUPPL	4	Null	7

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202884
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"16MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"32MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"32MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2013","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/04\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202884Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/12\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-02-12
        )

)