DR REDDYS FDA Approval ANDA 211034

ANDA 211034

DR REDDYS

FDA Drug Application

Application #211034

Application Sponsors

ANDA 211034DR REDDYS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG0ALBENDAZOLEALBENDAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211034
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBENDAZOLE","activeIngredients":"ALBENDAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-26
        )

)

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