NDA 018744

B BRAUN

FDA Drug Application

Application #018744

Application Sponsors

NDA 018744

B BRAUN

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML	0	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE
002	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML	0	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE
003	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML	0	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE
004	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML	0	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1982-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-09-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-10-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	1985-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-04-03	STANDARD
LABELING; Labeling	SUPPL	7	AP	1985-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-09-11	STANDARD

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	9	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18744
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;75MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;220MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;300MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;75MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;150MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;220MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;300MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)