AMNEAL FDA Approval ANDA 211374

ANDA 211374

AMNEAL

FDA Drug Application

Application #211374

Application Sponsors

ANDA 211374AMNEAL

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION500MG/VIAL0MYCOPHENOLATE MOFETIL HYDROCHLORIDEMYCOPHENOLATE MOFETIL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-05STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211374
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL HYDROCHLORIDE","activeIngredients":"MYCOPHENOLATE MOFETIL HYDROCHLORIDE","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-05
        )

)

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