NDA 019952

B BRAUN

FDA Drug Application

Application #019952

Documents

• Letter: 2004-04-20
• Letter: 2013-01-11
• Label: 2016-06-01
• Letter: 2011-12-29
• Letter: 2013-09-04
• Letter: 2016-05-27
• Label: 2009-03-17
• Label: 2011-12-23
• Label: 2013-01-11
• Label: 2013-09-09
• Letter: 2018-11-13

Application Sponsors

NDA 019952

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	4,000 UNITS/100ML	1	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM
004	INJECTABLE;INJECTION	5,000 UNITS/100ML	1	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM
005	INJECTABLE;INJECTION	10,000 UNITS/100ML	1	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	1992-07-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	1992-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-07-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2004-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2014-08-22	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-02-26	STANDARD
LABELING; Labeling	SUPPL	26	AP	2011-12-23	STANDARD
LABELING; Labeling	SUPPL	30	AP	2013-01-09	UNKNOWN
LABELING; Labeling	SUPPL	31	AP	2013-08-30	STANDARD
LABELING; Labeling	SUPPL	33	AP	2016-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2016-11-17	STANDARD
LABELING; Labeling	SUPPL	38	AP	2018-11-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	20	Null	0
SUPPL	26	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	15
SUPPL	33	Null	7
SUPPL	38	Null	15

TE Codes

001	Prescription	AP
004	Prescription	AP
005	Prescription	AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19952
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"4,000 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"HEPARIN SODIUM","strength":"10,000 UNITS\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/26\/2016","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019952s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2013","submission":"SUPPL-31","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019952s031lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2013","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019952s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2011","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019952s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019952s021lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"4,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"HEPARIN SODIUM","actionType":"10,000 UNITS\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-05-26
        )

)