ANDA 200832

APOTEX INC

FDA Drug Application

Application #200832

Application Sponsors

ANDA 200832

APOTEX INC

Marketing Status

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

Application Products

001	TABLET;ORAL	75MG	0	IRBESARTAN	IRBESARTAN
002	TABLET;ORAL	150MG	0	IRBESARTAN	IRBESARTAN
003	TABLET;ORAL	300MG	0	IRBESARTAN	IRBESARTAN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-10-15
LABELING; Labeling	SUPPL	2	AP	2015-10-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-12-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200832
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/15\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/06\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/15\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-12-06
        )

)