NDA 018030

B BRAUN

FDA Drug Application

Application #018030

Application Sponsors

NDA 018030

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	0	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
002	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
003	INJECTABLE;INJECTION	5GM/100ML;330MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
004	INJECTABLE;INJECTION	5GM/100ML;200MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
005	INJECTABLE;INJECTION	5GM/100ML;110MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1978-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1978-09-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	1978-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1978-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-10-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	1979-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1980-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1980-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1980-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1980-10-24	STANDARD
LABELING; Labeling	SUPPL	12	AP	1983-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1981-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1985-04-03	STANDARD
LABELING; Labeling	SUPPL	18	AP	1985-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	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	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	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18030
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"2.5GM\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;110MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;330MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"2.5GM\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;110MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;330MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)