APPLICATION
ANDA062420
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-15
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 31 · standardAP
2023-02-01Labeling · Supplement 25 · standardAP
2004-04-21Labeling · Supplement 14AP
2002-10-25Manufacturing (CMC) · Supplement 13AP
2001-03-22Manufacturing (CMC) · Supplement 12AP
2001-03-22Manufacturing (CMC) · Supplement 11AP
2000-01-07Labeling · Supplement 10AP
2000-01-07Manufacturing (CMC) · Supplement 9AP
1998-12-09Manufacturing (CMC) · Supplement 7AP
1998-09-18Manufacturing (CMC) · Supplement 8AP
1996-10-22Manufacturing (CMC) · Supplement 4AP
1996-10-03Manufacturing (CMC) · Supplement 5AP
1993-10-04Manufacturing (CMC) · Supplement 2AP
1993-07-13Labeling · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.