NOVITIUM PHARMA FDA Approval ANDA 214864

ANDA 214864

NOVITIUM PHARMA

FDA Drug Application

Application #214864

Documents

Letter2021-12-20

Application Sponsors

ANDA 214864NOVITIUM PHARMA

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL1GM/SCOOPFUL0BETAINEBETAINE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214864
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAINE","activeIngredients":"BETAINE","strength":"1GM\/SCOOPFUL","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-23
        )

)

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