NDA 018376

B BRAUN

FDA Drug Application

Application #018376

Application Sponsors

NDA 018376

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

2.5GM/100ML;900MG/100ML

0

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

DEXTROSE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1980-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1980-12-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	1983-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1981-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-04-03	STANDARD
LABELING; Labeling	SUPPL	10	AP	1985-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	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	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18376
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"2.5GM\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"2.5GM\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)