B BRAUN FDA Approval ANDA 091112

ANDA 091112

B BRAUN

FDA Drug Application

Application #091112

Application Sponsors

ANDA 091112B BRAUN

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION15%(150GM/1000ML)0AMINO ACIDSAMINO ACIDS
002INJECTABLE;INJECTION15%(300GM/2000ML)0AMINO ACIDSAMINO ACIDS

FDA Submissions

ORIG1AP2012-04-13
LABELING; LabelingSUPPL2AP2015-01-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91112
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINO ACIDS","activeIngredients":"AMINO ACIDS","strength":"15%(150GM\/1000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"AMINO ACIDS","activeIngredients":"AMINO ACIDS","strength":"15%(300GM\/2000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINO ACIDS","submission":"AMINO ACIDS","actionType":"15%(150GM\/1000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMINO ACIDS","submission":"AMINO ACIDS","actionType":"15%(300GM\/2000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.