APOTEX INC FDA Approval ANDA 203026

ANDA 203026

APOTEX INC

FDA Drug Application

Application #203026

Application Sponsors

ANDA 203026APOTEX INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005

Application Products

001TABLET;ORAL12.5MG;80MG0VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN
002TABLET;ORAL12.5MG;160MG0VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN
003TABLET;ORAL12.5MG;320MG0VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN
004TABLET;ORAL25MG;160MG0VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN
005TABLET;ORAL25MG;320MG0VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN

FDA Submissions

UNKNOWN; ORIG1AP2013-03-21
LABELING; LabelingSUPPL2AP2015-12-01STANDARD
LABELING; LabelingSUPPL3AP2015-12-01STANDARD
LABELING; LabelingSUPPL4AP2015-12-01STANDARD
LABELING; LabelingSUPPL5AP2015-12-01STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL3Null15
SUPPL4Null15
SUPPL5Null15

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203026
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"12.5MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"12.5MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"12.5MG;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"25MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"25MG;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/21\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/01\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/01\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/01\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/01\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-01
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.