APPLICATION
ANDA063106
TYPE
ANDA
ORIGINAL APPROVAL
1991-11-21
LATEST ACTION
1993-10-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION
Approval history
1993-10-04Manufacturing (CMC) · Supplement 4AP
1993-05-28Manufacturing (CMC) · Supplement 5AP
1993-05-28Manufacturing (CMC) · Supplement 3AP
1992-09-23Manufacturing (CMC) · Supplement 2AP
1992-05-08Manufacturing (CMC) · Supplement 1AP
1991-11-21OriginalAP
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.