ANDA 062814

B BRAUN

FDA Drug Application

Application #062814

Application Sponsors

ANDA 062814

B BRAUN

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 0.8MG BASE/ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
002	INJECTABLE;INJECTION	EQ 1.2MG BASE/ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
003	INJECTABLE;INJECTION	EQ 1.4MG BASE/ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
004	INJECTABLE;INJECTION	EQ 1.6MG BASE/ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
005	INJECTABLE;INJECTION	EQ 1.8MG BASE/ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
006	INJECTABLE;INJECTION	EQ 2MG BASE/ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
007	INJECTABLE;INJECTION	EQ 2.4MG BASE/ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
008	INJECTABLE;INJECTION	EQ 40MG BASE/100ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
009	INJECTABLE;INJECTION	EQ 60MG BASE/100ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
010	INJECTABLE;INJECTION	EQ 70MG BASE/100ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
011	INJECTABLE;INJECTION	EQ 80MG BASE/100ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
012	INJECTABLE;INJECTION	EQ 90MG BASE/100ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
013	INJECTABLE;INJECTION	EQ 100MG BASE/100ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE
014	INJECTABLE;INJECTION	EQ 120MG BASE/100ML	0	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE

FDA Submissions

	ORIG	1	AP	1987-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1992-01-29
LABELING; Labeling	SUPPL	5	AP	1992-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-03-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-08-21
LABELING; Labeling	SUPPL	12	AP	2004-08-31
LABELING; Labeling	SUPPL	13	AP	2005-06-07
LABELING; Labeling	SUPPL	15	AP	2006-12-07
LABELING; Labeling	SUPPL	16	AP	2007-09-12
LABELING; Labeling	SUPPL	17	AP	2008-11-20
LABELING; Labeling	SUPPL	18	AP	2009-11-30
LABELING; Labeling	SUPPL	21	AP	2010-05-13

Submissions Property Types

SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	18	Null	7

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62814
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 0.8MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.4MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.6MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.8MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 2.4MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 40MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 60MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 70MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 80MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 90MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 100MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 120MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 0.8MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.4MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.6MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.8MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 2.4MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 40MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 60MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 70MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 80MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 90MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 100MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 120MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)