NDA 019802

B BRAUN

FDA Drug Application

Application #019802

Application Sponsors

NDA 019802

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 005

Application Products

001	INJECTABLE;INJECTION	5,000 UNITS/100ML	0	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM
002	INJECTABLE;INJECTION	10,000 UNITS/100ML	0	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM
003	INJECTABLE;INJECTION	5,000 UNITS/100ML	0	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM
005	INJECTABLE;INJECTION	5,000 UNITS/100ML	0	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1992-07-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-12-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	1992-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2014-08-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	16	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19802
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"10,000 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% 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 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"10,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)