NOVITIUM PHARMA FDA Approval ANDA 215307

ANDA 215307

NOVITIUM PHARMA

FDA Drug Application

Application #215307

Application Sponsors

ANDA 215307NOVITIUM PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL0.125MG0DIGOXINDIGOXIN
002TABLET;ORAL0.25MG0DIGOXINDIGOXIN

FDA Submissions

UNKNOWN; ORIG1AP2021-11-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215307
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-22
        )

)

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