APPLICATION
ANDA062523
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-25
LATEST ACTION
1999-06-16
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
1999-06-16Manufacturing (CMC) · Supplement 21AP
1999-02-19Manufacturing (CMC) · Supplement 19AP
1999-02-02Manufacturing (CMC) · Supplement 16AP
1996-12-04Manufacturing (CMC) · Supplement 15AP
1996-04-16Manufacturing (CMC) · Supplement 14AP
1995-03-27Manufacturing (CMC) · Supplement 13AP
1994-10-18Labeling · Supplement 12AP
1994-01-27Labeling · Supplement 11AP
1992-02-11Manufacturing (CMC) · Supplement 7AP
1992-02-11Labeling · Supplement 8AP
1991-11-22Manufacturing (CMC) · Supplement 9AP
1991-10-16Labeling · Supplement 10AP
1988-07-29Manufacturing (CMC) · Supplement 6AP
1985-11-25OriginalAP
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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