APPLICATION
ANDA062356
TYPE
ANDA
ORIGINAL APPROVAL
1982-03-04
LATEST ACTION
2015-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
Approval history
2015-09-11Labeling · Supplement 24 · standardAP
2013-07-26Labeling · Supplement 23AP
2005-03-09Labeling · Supplement 18AP
2004-05-03Labeling · Supplement 17AP
2000-09-07Manufacturing (CMC) · Supplement 11AP
2000-03-21Manufacturing (CMC) · Supplement 10AP
2000-03-07Manufacturing (CMC) · Supplement 16AP
1995-02-23Manufacturing (CMC) · Supplement 13AP
1994-12-06Manufacturing (CMC) · Supplement 12AP
1993-05-21Labeling · Supplement 14AP
1991-03-18Labeling · Supplement 9AP
1982-03-04OriginalAP
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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