NDA 019024

B BRAUN

FDA Drug Application

Application #019024

Documents

• Letter: 2003-10-28

Application Sponsors

NDA 019024

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IRRIGATION

30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML

0

PHYSIOLYTE IN PLASTIC CONTAINER

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1984-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-07-08	STANDARD
LABELING; Labeling	SUPPL	15	AP	2003-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2013-05-08	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	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	21	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19024
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHYSIOLYTE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","strength":"30MG\/100ML;37MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHYSIOLYTE IN PLASTIC CONTAINER","submission":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","actionType":"30MG\/100ML;37MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)