AMNEAL FDA Approval ANDA 214871

ANDA 214871

AMNEAL

FDA Drug Application

Application #214871

Application Sponsors

ANDA 214871AMNEAL

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL200MG/ML0MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL

FDA Submissions

UNKNOWN; ORIG1AP2021-11-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214871
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"200MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-02
        )

)

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