B BRAUN FDA Approval NDA 020004

NDA 020004

B BRAUN

FDA Drug Application

Application #020004

Application Sponsors

NDA 020004B BRAUN

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION1.87GM/100ML0SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINERSODIUM LACTATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1992-04-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-08-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2000-12-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-04-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2002-07-01STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20004
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM LACTATE 1\/6 MOLAR IN PLASTIC CONTAINER","activeIngredients":"SODIUM LACTATE","strength":"1.87GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM LACTATE 1\/6 MOLAR IN PLASTIC CONTAINER","submission":"SODIUM LACTATE","actionType":"1.87GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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