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FDA ANDA · ANDA062814
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
ANDA062814
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-28
LATEST ACTION
2010-05-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 60MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 2.4MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 100MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 1.8MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 80MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 1.4MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 0.8MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 40MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 120MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 2MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 90MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 1.6MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 70MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 1.2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2010-05-13Labeling · Supplement 21AP
2009-11-30Labeling · Supplement 18AP
2008-11-20Labeling · Supplement 17AP
2007-09-12Labeling · Supplement 16AP
2006-12-07Labeling · Supplement 15AP
2005-06-07Labeling · Supplement 13AP
2004-08-31Labeling · Supplement 12AP
2001-08-21Manufacturing (CMC) · Supplement 10AP
2001-08-03Manufacturing (CMC) · Supplement 9AP
1997-05-16Manufacturing (CMC) · Supplement 8AP
1996-03-01Manufacturing (CMC) · Supplement 7AP
1992-11-18Labeling · Supplement 5AP
1992-01-29Manufacturing (CMC) · Supplement 4AP
1987-08-28OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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