HARMAN FINOCHEM FDA Approval ANDA 214443

ANDA 214443

HARMAN FINOCHEM

FDA Drug Application

Application #214443

Application Sponsors

ANDA 214443HARMAN FINOCHEM

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL100MG0ALLOPURINOLALLOPURINOL
002TABLET;ORAL300MG0ALLOPURINOLALLOPURINOL

FDA Submissions

UNKNOWN; ORIG1AP2022-03-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HARMAN FINOCHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214443
            [companyName] => HARMAN FINOCHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALLOPURINOL","activeIngredients":"ALLOPURINOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALLOPURINOL","activeIngredients":"ALLOPURINOL","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-07
        )

)

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