XELLIA PHARMS APS FDA Approval ANDA 211713

ANDA 211713

XELLIA PHARMS APS

FDA Drug Application

Application #211713

Application Sponsors

ANDA 211713XELLIA PHARMS APS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INTRAVENOUSEQ 50MG BASE/VIAL0MICAFUNGIN SODIUMMICAFUNGIN SODIUM
002INJECTABLE;INTRAVENOUSEQ 100MG BASE/VIAL0MICAFUNGIN SODIUMMICAFUNGIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-06-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

XELLIA PHARMS APS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211713
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICAFUNGIN SODIUM","activeIngredients":"MICAFUNGIN SODIUM","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MICAFUNGIN SODIUM","activeIngredients":"MICAFUNGIN SODIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-02
        )

)

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