NDA 019873

B BRAUN

FDA Drug Application

Application #019873

Application Sponsors

NDA 019873

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5GM/100ML;31MG/100ML;130MG/100ML;26MG/100ML;320MG/100ML

0

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER

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

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	2000-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	11	AP	2004-05-11

Submissions Property Types

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	10	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19873
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE","strength":"5GM\/100ML;31MG\/100ML;130MG\/100ML;26MG\/100ML;320MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE","actionType":"5GM\/100ML;31MG\/100ML;130MG\/100ML;26MG\/100ML;320MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)