NDA 019843

B BRAUN

FDA Drug Application

Application #019843

Application Sponsors

NDA 019843

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5GM/100ML;30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML

0

ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1993-08-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-07-01	STANDARD

Submissions Property Types

ORIG	1	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	10	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19843
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","strength":"5GM\/100ML;30MG\/100ML;37MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","actionType":"5GM\/100ML;30MG\/100ML;37MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)