NDA 019635

B BRAUN

FDA Drug Application

Application #019635

Documents

• Label: 2014-09-09

Application Sponsors

NDA 019635

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	450MG/100ML	1	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE
002	INJECTABLE;INJECTION	900MG/100ML	1	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE
003	INJECTABLE;INJECTION	3GM/100ML	0	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE
004	INJECTABLE;INJECTION	5GM/100ML	0	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	SODIUM CHLORIDE
005	INJECTABLE;INJECTION	9MG/10ML	1	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1988-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-11-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-06-13
LABELING; Labeling	SUPPL	22	AP	2004-02-04
LABELING; Labeling	SUPPL	23	AP	2004-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2014-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2015-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2015-07-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2015-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2016-04-26	STANDARD

Submissions Property Types

SUPPL	2	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	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	41	Null	0

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19635
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM CHLORIDE","strength":"9MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"SODIUM CHLORIDE 3% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"3GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SODIUM CHLORIDE 5% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"5GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/08\/2014","submission":"SUPPL-35","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019635s035lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SODIUM CHLORIDE 0.9%","submission":"SODIUM CHLORIDE","actionType":"9MG\/10ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SODIUM CHLORIDE 3% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"3GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SODIUM CHLORIDE 5% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"5GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-09-08
        )

)