NDA 019844

B BRAUN

FDA Drug Application

Application #019844

Application Sponsors

NDA 019844

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5GM/100ML;30MG/100ML;97MG/100ML;220MG/100ML;140MG/100ML

0

ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; 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	1995-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	2004-05-14

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19844
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"5GM\/100ML;30MG\/100ML;97MG\/100ML;220MG\/100ML;140MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"5GM\/100ML;30MG\/100ML;97MG\/100ML;220MG\/100ML;140MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)