NDA 019134

B BRAUN

FDA Drug Application

Application #019134

Application Sponsors

NDA 019134

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5,000 UNITS/100ML

0

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

HEPARIN SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1985-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-10-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	1987-08-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	1987-12-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	1988-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-04-20	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19134
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)