NDA 018725

B BRAUN

FDA Drug Application

Application #018725

Application Sponsors

NDA 018725

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

20MG/100ML;30MG/100ML;380MG/100ML;600MG/100ML

0

ACETATED RINGER'S IN PLASTIC CONTAINER

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1982-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-04-03	STANDARD
LABELING; Labeling	SUPPL	4	AP	1985-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-09-11	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18725
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETATED RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"20MG\/100ML;30MG\/100ML;380MG\/100ML;600MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETATED RINGER'S IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"20MG\/100ML;30MG\/100ML;380MG\/100ML;600MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)