NDA 019708

B BRAUN

FDA Drug Application

Application #019708

Documents

• Label: 2004-09-29
• Letter: 2004-09-29
• Letter: 2005-09-08

Application Sponsors

NDA 019708

B BRAUN

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	37MG/100ML;900MG/100ML	0	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE
002	INJECTABLE;INJECTION	75MG/100ML;900MG/100ML	0	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE
003	INJECTABLE;INJECTION	110MG/100ML;900MG/100ML	0	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE
004	INJECTABLE;INJECTION	150MG/100ML;900MG/100ML	0	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE
005	INJECTABLE;INJECTION	220MG/100ML;900MG/100ML	0	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE
006	INJECTABLE;INJECTION	300MG/100ML;900MG/100ML	0	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM 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	1992-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-05-04	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
LABELING; Labeling	SUPPL	16	AP	2005-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2014-08-22	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	22	Null	0

TE Codes

004

Prescription

AP

CDER Filings

B BRAUN

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(
    [0] => Array
        (
            [ApplNo] => 19708
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"37MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"75MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"110MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"150MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"220MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"300MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/27\/2004","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19708s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"37MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"75MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"110MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"150MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"220MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"300MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2004-09-27
        )

)