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FDA ANDA · ANDA062414
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
ANDA062414
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-15
LATEST ACTION
2023-02-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
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 60MG 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 100MG 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 90MG BASE/100ML · 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 2MG BASE/ML · 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 1.2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 58 · standardAP
2016-06-23Labeling · Supplement 54 · standardAP
2004-04-19Labeling · Supplement 32AP
2002-11-01Manufacturing (CMC) · Supplement 31AP
1998-12-09Manufacturing (CMC) · Supplement 28AP
1998-12-01Manufacturing (CMC) · Supplement 30AP
1998-09-18Manufacturing (CMC) · Supplement 29AP
1997-06-02Manufacturing (CMC) · Supplement 26AP
1997-04-08Manufacturing (CMC) · Supplement 24AP
1996-07-03Manufacturing (CMC) · Supplement 21AP
1996-03-12Manufacturing (CMC) · Supplement 23AP
1994-04-25Labeling · Supplement 19AP
1993-10-04Manufacturing (CMC) · Supplement 18AP
1993-07-28Labeling · Supplement 17AP
1992-03-10Manufacturing (CMC) · Supplement 16AP
1992-01-06Manufacturing (CMC) · Supplement 13AP
1991-01-18Manufacturing (CMC) · Supplement 15AP
1990-08-02Manufacturing (CMC) · Supplement 14AP
1990-03-22Manufacturing (CMC) · Supplement 12AP
1983-08-15OriginalAP
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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