AM REGENT FDA Approval ANDA 065151

ANDA 065151

AM REGENT

FDA Drug Application

Application #065151

Application Sponsors

ANDA 065151AM REGENT

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION50MG/ML0CYCLOSPORINECYCLOSPORINE

FDA Submissions

ORIG1AP2003-10-07
LABELING; LabelingSUPPL3AP2005-06-24
LABELING; LabelingSUPPL4AP2006-10-10
LABELING; LabelingSUPPL9AP2012-01-31
LABELING; LabelingSUPPL10AP2015-06-30
LABELING; LabelingSUPPL13AP2015-06-30STANDARD

Submissions Property Types

SUPPL9Null15
SUPPL10Null15
SUPPL13Null7

TE Codes

001PrescriptionAP

CDER Filings

PADAGIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65151
            [companyName] => PADAGIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOSPORINE","submission":"CYCLOSPORINE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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