FRESENIUS KABI USA FDA Approval ANDA 212248

ANDA 212248

FRESENIUS KABI USA

FDA Drug Application

Application #212248

Documents

Letter2021-05-11

Application Sponsors

ANDA 212248FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION234MG/ML0SODIUM CHLORIDE 23.4%SODIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212248
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 23.4%","activeIngredients":"SODIUM CHLORIDE","strength":"234MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-28
        )

)

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