NDA 018252

B BRAUN

FDA Drug Application

Application #018252

Application Sponsors

NDA 018252

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

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

0

ISOLYTE S IN PLASTIC CONTAINER

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

FDA Submissions

	ORIG	1	AP	1980-08-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1980-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-12-10
LABELING; Labeling	SUPPL	5	AP	1981-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1981-10-26
LABELING; Labeling	SUPPL	8	AP	1983-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1987-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-04-03
LABELING; Labeling	SUPPL	13	AP	1985-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1987-10-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1990-09-11

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] => 18252
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE S IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","strength":"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 PLASTIC CONTAINER","submission":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","actionType":"30MG\/100ML;37MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)