B BRAUN FDA Approval NDA 020002

NDA 020002

B BRAUN

FDA Drug Application

Application #020002

Documents

Letter2021-11-04
Label2021-11-05

Application Sponsors

NDA 020002B BRAUN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION33MG/100ML;30MG/100ML;860MG/100ML0RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1992-04-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1993-07-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-08-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-12-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-04-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2002-07-01STANDARD
LABELING; LabelingSUPPL10AP2004-06-16
LABELING; LabelingSUPPL32AP2021-11-03STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL32Null6

TE Codes

001PrescriptionAP

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20002
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"33MG\/100ML;30MG\/100ML;860MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RINGER'S IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"33MG\/100ML;30MG\/100ML;860MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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