NDA 018268

B BRAUN

FDA Drug Application

Application #018268

Application Sponsors

NDA 018268

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006
• Discontinued: 009
• Discontinued: 010
• Discontinued: 011
• Discontinued: 012
• Discontinued: 013
• Discontinued: 014

Application Products

001	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;450MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
002	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML;450MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
003	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;450MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
004	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;200MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
005	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML;200MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
006	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;200MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
009	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;200MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
010	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;450MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
011	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;330MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
012	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;330MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
013	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML;330MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
014	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;330MG/100ML	0	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1980-09-05	STANDARD
LABELING; Labeling	SUPPL	2	AP	1981-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1980-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1981-01-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1980-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1980-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1981-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-06-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	1984-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1986-01-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	1986-01-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-04-03	STANDARD
LABELING; Labeling	SUPPL	16	AP	1985-06-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	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	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18268
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;75MG\/100ML;200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML;200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;220MG\/100ML;200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;300MG\/100ML;200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;75MG\/100ML;330MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML;330MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;220MG\/100ML;330MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;300MG\/100ML;330MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;75MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;220MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;300MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;75MG\/100ML;200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;150MG\/100ML;200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;220MG\/100ML;200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;300MG\/100ML;200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;75MG\/100ML;330MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;150MG\/100ML;330MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;220MG\/100ML;330MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;300MG\/100ML;330MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;75MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;150MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;220MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;300MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)