RUBICON FDA Approval ANDA 212044

ANDA 212044

RUBICON

FDA Drug Application

Application #212044

Application Sponsors

ANDA 212044RUBICON

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG0AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212044
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-21
        )

)

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