FRESENIUS KABI USA FDA Approval ANDA 212483

ANDA 212483

FRESENIUS KABI USA

FDA Drug Application

Application #212483

Application Sponsors

ANDA 212483FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION2.4GM/100ML0FOSCARNET SODIUMFOSCARNET SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-01-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212483
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSCARNET SODIUM","activeIngredients":"FOSCARNET SODIUM","strength":"2.4GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOSCARNET SODIUM","submission":"FOSCARNET SODIUM","actionType":"2.4GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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