NDA 018269

B BRAUN

FDA Drug Application

Application #018269

Application Sponsors

NDA 018269

B BRAUN

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;INJECTION

35MG/100ML;5GM/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/100ML

0

ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1980-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1980-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-12-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	1981-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1981-10-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	1983-01-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-04-03	STANDARD
LABELING; Labeling	SUPPL	12	AP	1985-11-25	STANDARD
LABELING; Labeling	SUPPL	13	AP	1987-07-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	1987-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	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	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18269
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE E W\/ DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE","strength":"35MG\/100ML;5GM\/100ML;30MG\/100ML;74MG\/100ML;640MG\/100ML;500MG\/100ML;74MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOLYTE E W\/ DEXTROSE 5% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE","actionType":"35MG\/100ML;5GM\/100ML;30MG\/100ML;74MG\/100ML;640MG\/100ML;500MG\/100ML;74MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)