NDA 019006

B BRAUN

FDA Drug Application

Application #019006

Application Sponsors

NDA 019006

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

30MG/100ML;37MG/100ML;0.82MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML;12MG/100ML

0

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1984-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-09-11	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19006
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE S PH 7.4 IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","strength":"30MG\/100ML;37MG\/100ML;0.82MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML;12MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOLYTE S PH 7.4 IN PLASTIC CONTAINER","submission":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","actionType":"30MG\/100ML;37MG\/100ML;0.82MG\/100ML;370MG\/100ML;530MG\/100ML;500MG\/100ML;12MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)