APPLICATION
ANDA062612
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-20
LATEST ACTION
2004-03-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
Approval history
2004-03-24Labeling · Supplement 16AP
2003-03-06Labeling · Supplement 15AP
2001-04-09Manufacturing (CMC) · Supplement 14AP
1998-12-09Manufacturing (CMC) · Supplement 11AP
1998-09-25Manufacturing (CMC) · Supplement 13AP
1998-09-25Manufacturing (CMC) · Supplement 12AP
1995-05-10Manufacturing (CMC) · Supplement 9AP
1994-01-14Manufacturing (CMC) · Supplement 8AP
1993-10-04Manufacturing (CMC) · Supplement 7AP
1992-10-30Manufacturing (CMC) · Supplement 6AP
1992-04-28Manufacturing (CMC) · Supplement 5AP
1991-06-20Labeling · Supplement 4AP
1986-02-20OriginalAP
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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