PRINSTON INC FDA Approval ANDA 213273

ANDA 213273

PRINSTON INC

FDA Drug Application

Application #213273

Application Sponsors

ANDA 213273PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL2.5MG0ENALAPRIL MALEATEENALAPRIL MALEATE
002TABLET;ORAL5MG0ENALAPRIL MALEATEENALAPRIL MALEATE
003TABLET;ORAL10MG0ENALAPRIL MALEATEENALAPRIL MALEATE
004TABLET;ORAL20MG0ENALAPRIL MALEATEENALAPRIL MALEATE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213273
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-07
        )

)

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