APOTEX INC FDA Approval ANDA 201505

ANDA 201505

APOTEX INC

FDA Drug Application

Application #201505

Application Sponsors

ANDA 201505APOTEX INC

Marketing Status

Discontinued001
Discontinued002
None (Tentative Approval)003

Application Products

001TABLET;ORAL12.5MG;150MG0IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN
002TABLET;ORAL12.5MG;300MG0IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN
003TABLET; ORAL25MG;300MG0IRBESARTAN HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN

FDA Submissions

N/A; Not ApplicableORIG1AP2012-10-15
N/A; Not ApplicableORIG2TA2012-10-15
LABELING; LabelingSUPPL4AP2015-02-17STANDARD

Submissions Property Types

ORIG1Null1
ORIG2Null1
SUPPL4Null7

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
        )

)

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