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FDA ANDA · ANDA062373
GENTAMICIN SULFATE IN SODIUM CHLORIDE
gentamicin sulfate
Sponsor: BAXTER HLTHCARE
APPLICATION
ANDA062373
TYPE
ANDA
ORIGINAL APPROVAL
1982-09-07
LATEST ACTION
2023-02-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
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 CONTAINERPrescription
GENTAMICIN SULFATE EQ 80MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
GENTAMICIN SULFATE EQ 2MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
GENTAMICIN SULFATE EQ 1.2MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
GENTAMICIN SULFATE EQ 100MG BASE/100ML · 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 0.8MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
GENTAMICIN SULFATE EQ 1.6MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
GENTAMICIN SULFATE EQ 120MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 60MG BASE/100ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 44 · standardAP
2023-01-31Labeling · Supplement 42 · standardAP
2023-01-31Labeling · Supplement 40 · standardAP
2015-12-11Labeling · Supplement 39 · standardAP
2013-07-30Labeling · Supplement 35AP
2009-11-30Labeling · Supplement 33AP
2007-11-05Labeling · Supplement 32AP
2004-08-31Labeling · Supplement 31AP
1997-12-29Manufacturing (CMC) · Supplement 27AP
1997-05-21Manufacturing (CMC) · Supplement 26AP
1995-01-27Manufacturing (CMC) · Supplement 24AP
1994-10-17Manufacturing (CMC) · Supplement 25AP
1994-10-17Manufacturing (CMC) · Supplement 21AP
1994-06-28Manufacturing (CMC) · Supplement 23AP
1994-02-25Manufacturing (CMC) · Supplement 22AP
1993-08-04Manufacturing (CMC) · Supplement 20AP
1991-09-10Labeling · Supplement 19AP
1991-06-06Manufacturing (CMC) · Supplement 18AP
1991-03-20Manufacturing (CMC) · Supplement 17AP
1991-02-07Manufacturing (CMC) · Supplement 16AP
1989-05-12Manufacturing (CMC) · Supplement 15AP
1982-09-07OriginalAP
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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