APPLICATION
ANDA062635
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-08
LATEST ACTION
2002-03-08
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-03-08Manufacturing (CMC) · Supplement 14AP
2000-03-15Manufacturing (CMC) · Supplement 13AP
1999-06-07Manufacturing (CMC) · Supplement 12AP
1998-09-30Labeling · Supplement 10AP
1998-09-30Labeling · Supplement 11AP
1995-10-03Manufacturing (CMC) · Supplement 8AP
1995-10-03Manufacturing (CMC) · Supplement 6AP
1995-10-03Manufacturing (CMC) · Supplement 4AP
1995-10-03Labeling · Supplement 9AP
1995-10-03Manufacturing (CMC) · Supplement 7AP
1995-10-03Manufacturing (CMC) · Supplement 5AP
1991-10-22Labeling · Supplement 2AP
1987-01-08OriginalAP
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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