NDA 019699

B BRAUN

FDA Drug Application

Application #019699

Documents

• Letter: 2004-09-29
• Label: 2004-09-29
• Letter: 2020-07-13
• Label: 2020-07-14

Application Sponsors

NDA 019699

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Prescription: 004
• Discontinued: 005
• Prescription: 006

Application Products

001	INJECTABLE;INJECTION	5GM/100ML;37MG/100ML	0	POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE
002	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML	0	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE
003	INJECTABLE;INJECTION	5GM/100ML;110MG/100ML	0	POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE
004	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML	0	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE
005	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML	0	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE
006	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML	0	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1989-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1993-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-03-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-03-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-07-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2004-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-08-22	STANDARD
LABELING; Labeling	SUPPL	33	AP	2020-07-10	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	21	Null	0
SUPPL	33	Null	7

TE Codes

004	Prescription	AP
006	Prescription	AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19699
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;37MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;75MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;110MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;220MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;300MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/10\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019699s033lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019699s033lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2004","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19699s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;37MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;75MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;110MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;150MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;220MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE","actionType":"5GM\/100ML;300MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-07-10
        )

)