NDA 019870

B BRAUN

FDA Drug Application

Application #019870

Application Sponsors

NDA 019870

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML

0

ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1993-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	9	AP	2004-05-11

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19870
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML;130MG\/100ML;280MG\/100ML;91MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"5GM\/100ML;150MG\/100ML;130MG\/100ML;280MG\/100ML;91MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)