HIKMA FDA Approval ANDA 213261

ANDA 213261

HIKMA

FDA Drug Application

Application #213261

Application Sponsors

ANDA 213261HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2021-07-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213261
            [companyName] => HIKMA
            [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":"07\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-09
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.