NDA 019953

B BRAUN

FDA Drug Application

Application #019953

Documents

• Letter: 2004-04-20
• Letter: 2009-03-03
• Label: 2016-05-17
• Letter: 2011-12-29
• Letter: 2013-01-14
• Letter: 2013-09-04
• Letter: 2016-05-16
• Label: 2009-03-17
• Label: 2011-12-23
• Label: 2013-01-11
• Label: 2013-09-09

Application Sponsors

NDA 019953

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200 UNITS/100ML

1

HEPARIN SODIUM 1,000 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	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	4	AP	1995-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	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	25	AP	2011-12-27	STANDARD
LABELING; Labeling	SUPPL	29	AP	2013-01-10	STANDARD
LABELING; Labeling	SUPPL	30	AP	2013-08-30	STANDARD
LABELING; Labeling	SUPPL	32	AP	2016-05-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	20	Null	0
SUPPL	25	Null	15
SUPPL	29	Null	15
SUPPL	30	Null	6
SUPPL	32	Null	6

TE Codes

001

Prescription

AP

CDER Filings

B BRAUN

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(
    [0] => Array
        (
            [ApplNo] => 19953
            [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":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/12\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019953s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2013","submission":"SUPPL-30","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019953s030lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2013","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019953s030lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2013","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019953s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/27\/2011","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019953s025lbl.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\\\/019953s021lbl.pdf\"}]","notes":""}]
            [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":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-05-12
        )

)