APPLICATION
ANDA062452
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-10
LATEST ACTION
2004-02-20
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
GENOPTICDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2004-02-20Labeling · Supplement 19AP
2002-11-15Manufacturing (CMC) · Supplement 22AP
2002-07-03Manufacturing (CMC) · Supplement 21AP
2001-08-15Manufacturing (CMC) · Supplement 20AP
2000-12-08Manufacturing (CMC) · Supplement 17AP
1998-10-16Manufacturing (CMC) · Supplement 16AP
1998-04-03Manufacturing (CMC) · Supplement 13AP
1998-02-24Manufacturing (CMC) · Supplement 15AP
1997-10-22Manufacturing (CMC) · Supplement 14AP
1995-01-31Labeling · Supplement 12AP
1994-09-27Manufacturing (CMC) · Supplement 10AP
1994-07-01Manufacturing (CMC) · Supplement 11AP
1993-09-27Labeling · Supplement 9AP
1992-02-28Labeling · Supplement 8AP
1991-04-11Manufacturing (CMC) · Supplement 5AP
1991-02-26Manufacturing (CMC) · Supplement 7AP
1989-04-05Manufacturing (CMC) · Supplement 6AP
1988-11-22Manufacturing (CMC) · Supplement 4AP
1984-10-10OriginalAP
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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