NOVITIUM PHARMA FDA Approval ANDA 215560

ANDA 215560

NOVITIUM PHARMA

FDA Drug Application

Application #215560

Application Sponsors

ANDA 215560NOVITIUM PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL50MG;25MG0ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE
002TABLET;ORAL100MG;25MG0ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE

FDA Submissions

UNKNOWN; ORIG1AP2021-10-25STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215560
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"50MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-25
        )

)

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