RUBICON FDA Approval ANDA 214896

ANDA 214896

RUBICON

FDA Drug Application

Application #214896

Application Sponsors

ANDA 214896RUBICON

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL50MG0PRIMIDONEPRIMIDONE
002TABLET;ORAL250MG0PRIMIDONEPRIMIDONE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-28STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214896
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRIMIDONE","activeIngredients":"PRIMIDONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRIMIDONE","activeIngredients":"PRIMIDONE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-28
        )

)

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