ANDA 201505

APOTEX INC

FDA Drug Application

Application #201505

Application Sponsors

ANDA 201505

APOTEX INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• None (Tentative Approval): 003

Application Products

001	TABLET;ORAL	12.5MG;150MG	0	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN
002	TABLET;ORAL	12.5MG;300MG	0	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN
003	TABLET; ORAL	25MG;300MG	0	IRBESARTAN HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-10-15
N/A; Not Applicable	ORIG	2	TA	2012-10-15
LABELING; Labeling	SUPPL	4	AP	2015-02-17	STANDARD

Submissions Property Types

ORIG	1	Null	1
ORIG	2	Null	1
SUPPL	4	Null	7

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201505
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"25MG;300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/15\/2012","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/15\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/17\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/17\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-02-17
        )

)