NDA 019042

B BRAUN

FDA Drug Application

Application #019042

Application Sponsors

NDA 019042

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 004

Application Products

001	INJECTABLE;INJECTION	200 UNITS/100ML	0	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM
002	INJECTABLE;INJECTION	200 UNITS/100ML	0	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM
004	INJECTABLE;INJECTION	1,000 UNITS/100ML	0	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 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	1987-04-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	1989-06-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-04-20	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19042
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"200 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"200 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"1,000 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"200 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"200 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"1,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)