B BRAUN MEDICAL INC FDA Approval ANDA 207967

ANDA 207967

B BRAUN MEDICAL INC

FDA Drug Application

Application #207967

Application Sponsors

ANDA 207967B BRAUN MEDICAL INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION2GM/50ML (40MG/ML)0MAGNESIUM SULFATEMAGNESIUM SULFATE
002INJECTABLE;INJECTION4GM/100ML (40MG/ML)0MAGNESIUM SULFATEMAGNESIUM SULFATE
003INJECTABLE;INJECTION4GM/50ML (80MG/ML)0MAGNESIUM SULFATEMAGNESIUM SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

B BRAUN MEDICAL INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207967
            [companyName] => B BRAUN MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE","strength":"2GM\/50ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/100ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/50ML (80MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-26
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.