NDA 019696

B BRAUN

FDA Drug Application

Application #019696

Application Sponsors

NDA 019696

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

30MG/100ML;37MG/100ML;0.82MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML;12MG/100ML

1

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

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	8	AP	1994-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	20	AP	2004-05-14

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	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	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19696
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE S PH 7.4 IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","strength":"30MG\/100ML;37MG\/100ML;0.82MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML;12MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOLYTE S PH 7.4 IN PLASTIC CONTAINER","submission":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","actionType":"30MG\/100ML;37MG\/100ML;0.82MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML;12MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)