APPLICATION
ANDA062366
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-04
LATEST ACTION
2023-02-10
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GENTAMICIN SULFATEPrescription
GENTAMICIN SULFATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATEPrescription
GENTAMICIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 40 · standardAP
2023-02-10Labeling · Supplement 39 · standardAP
2023-02-10Labeling · Supplement 45 · standardAP
2013-07-26Labeling · Supplement 35AP
2005-03-09Labeling · Supplement 26AP
2004-05-03Labeling · Supplement 25AP
2002-12-05Manufacturing (CMC) · Supplement 24AP
2001-12-28Manufacturing (CMC) · Supplement 22AP
2000-03-07Manufacturing (CMC) · Supplement 20AP
1994-12-06Manufacturing (CMC) · Supplement 16AP
1993-06-22Labeling · Supplement 18AP
1992-08-27Labeling · Supplement 17AP
1991-11-26Manufacturing (CMC) · Supplement 11AP
1991-06-19Manufacturing (CMC) · Supplement 12AP
1991-03-18Labeling · Supplement 15AP
1990-09-11Labeling · Supplement 14AP
1983-08-04OriginalAP
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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