FRESENIUS KABI USA FDA Approval ANDA 212070

ANDA 212070

FRESENIUS KABI USA

FDA Drug Application

Application #212070

Documents

Letter2021-05-06

Application Sponsors

ANDA 212070FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS50MEQ/20ML (2.5MEQ/ML)0SODIUM CHLORIDE 14.6%SODIUM CHLORIDE
002SOLUTION;INTRAVENOUS100MEQ/40ML (2.5MEQ/ML)0SODIUM CHLORIDE 14.6%SODIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

002PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212070
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 14.6%","activeIngredients":"SODIUM CHLORIDE","strength":"50MEQ\/20ML (2.5MEQ\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM CHLORIDE 14.6%","activeIngredients":"SODIUM CHLORIDE","strength":"100MEQ\/40ML (2.5MEQ\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212070Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-28
        )

)

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