NDA 018807

B BRAUN

FDA Drug Application

Application #018807

Application Sponsors

NDA 018807

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	SOLUTION;INTRAPERITONEAL	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	0	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
002	SOLUTION;INTRAPERITONEAL	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	0	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
003	SOLUTION;INTRAPERITONEAL	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	0	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
004	SOLUTION;INTRAPERITONEAL	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	0	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1983-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-04-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	1988-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-04-05	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18807
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIALYTE CONCENTRATE W\/ DEXTROSE 30% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"510MG\/100ML;30GM\/100ML;200MG\/100ML;9.2GM\/100ML;9.6GM\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE CONCENTRATE W\/ DEXTROSE 30% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"510MG\/100ML;30GM\/100ML;200MG\/100ML;9.4GM\/100ML;11GM\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE CONCENTRATE W\/ DEXTROSE 50% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"510MG\/100ML;50GM\/100ML;200MG\/100ML;9.2GM\/100ML;9.6GM\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE CONCENTRATE W\/ DEXTROSE 50% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"510MG\/100ML;50GM\/100ML;200MG\/100ML;9.4GM\/100ML;11GM\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIALYTE CONCENTRATE W\/ DEXTROSE 30% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"510MG\/100ML;30GM\/100ML;200MG\/100ML;9.2GM\/100ML;9.6GM\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE CONCENTRATE W\/ DEXTROSE 30% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"510MG\/100ML;30GM\/100ML;200MG\/100ML;9.4GM\/100ML;11GM\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE CONCENTRATE W\/ DEXTROSE 50% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"510MG\/100ML;50GM\/100ML;200MG\/100ML;9.2GM\/100ML;9.6GM\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE CONCENTRATE W\/ DEXTROSE 50% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"510MG\/100ML;50GM\/100ML;200MG\/100ML;9.4GM\/100ML;11GM\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)