BAXTER HLTHCARE CORP FDA Approval ANDA 211965

ANDA 211965

BAXTER HLTHCARE CORP

FDA Drug Application

Application #211965

Application Sponsors

ANDA 211965BAXTER HLTHCARE CORP

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1GM/100ML0MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERMAGNESIUM SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211965
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"1GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-11
        )

)

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