FRESENIUS KABI USA FDA Approval ANDA 212441

ANDA 212441

FRESENIUS KABI USA

FDA Drug Application

Application #212441

Application Sponsors

ANDA 212441FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION200 UNITS/100ML0HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHEPARIN SODIUM
002INJECTABLE;INJECTION200 UNITS/100ML0HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHEPARIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-07-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212441
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"200 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"200 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-24
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.