DR REDDYS LABS LTD FDA Approval ANDA 203500

ANDA 203500

DR REDDYS LABS LTD

FDA Drug Application

Application #203500

Application Sponsors

ANDA 203500DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2012-09-27

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203500
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-09-27
        )

)

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