NDA 019718

B BRAUN

FDA Drug Application

Application #019718

Application Sponsors

NDA 019718

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

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

0

ISOLYTE E IN PLASTIC CONTAINER

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

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1989-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-11-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-07-01	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19718
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE E IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE","strength":"35MG\/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 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE","actionType":"35MG\/100ML;30MG\/100ML;74MG\/100ML;640MG\/100ML;500MG\/100ML;74MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)