NDA 019631

B BRAUN

FDA Drug Application

Application #019631

Documents

• Letter: 2004-09-29
• Label: 2004-09-29

Application Sponsors

NDA 019631

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Prescription: 009
• Prescription: 010
• Prescription: 011
• Prescription: 012
• Prescription: 013
• Prescription: 014
• Prescription: 015
• Prescription: 016

Application Products

001	INJECTABLE;INJECTION	2.5GM/100ML;110MG/100ML	0	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
002	INJECTABLE;INJECTION	2.5GM/100ML;200MG/100ML	0	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
003	INJECTABLE;INJECTION	2.5GM/100ML;330MG/100ML	0	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
004	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	0	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
005	INJECTABLE;INJECTION	2.5GM/100ML;900MG/100ML	0	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
006	INJECTABLE;INJECTION	5GM/100ML;110MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
007	INJECTABLE;INJECTION	5GM/100ML;200MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
008	INJECTABLE;INJECTION	5GM/100ML;330MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
009	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
010	INJECTABLE;INJECTION	5GM/100ML;900MG/100ML	0	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
011	INJECTABLE;INJECTION	10GM/100ML;110MG/100ML	0	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
012	INJECTABLE;INJECTION	10GM/100ML;200MG/100ML	0	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
013	INJECTABLE;INJECTION	10GM/100ML;330MG/100ML	0	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
014	INJECTABLE;INJECTION	10GM/100ML;450MG/100ML	0	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
015	INJECTABLE;INJECTION	10GM/100ML;900MG/100ML	0	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE
016	INJECTABLE;INJECTION	3.3GM/100ML;300MG/100ML	0	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1988-02-24	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	1990-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-04-13	STANDARD
LABELING; Labeling	SUPPL	9	AP	1990-01-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1990-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1991-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1994-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1995-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-03-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-03-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-07-23	STANDARD
LABELING; Labeling	SUPPL	23	AP	2004-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2014-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2014-01-24	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	10	Null	0
SUPPL	11	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	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	31	Null	0
SUPPL	34	Null	0

TE Codes

004	Prescription	AP
007	Prescription	AP
008	Prescription	AP
009	Prescription	AP
010	Prescription	AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19631
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"10GM\/100ML;110MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"10GM\/100ML;200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"10GM\/100ML;330MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"10GM\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"10GM\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"2.5GM\/100ML;110MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"2.5GM\/100ML;200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"2.5GM\/100ML;330MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"2.5GM\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"2.5GM\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"3.3GM\/100ML;300MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;110MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;330MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/27\/2004","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19631s023lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"10GM\/100ML;110MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"10GM\/100ML;200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"10GM\/100ML;330MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"10GM\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"10GM\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"2.5GM\/100ML;110MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"2.5GM\/100ML;200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"2.5GM\/100ML;330MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"2.5GM\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"2.5GM\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"3.3GM\/100ML;300MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;110MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;330MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2004-09-27
        )

)