APPLICATION
ANDA062480
TYPE
ANDA
ORIGINAL APPROVAL
1984-03-30
LATEST ACTION
2001-04-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
GENTACIDINDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2001-04-19Manufacturing (CMC) · Supplement 9AP
1999-02-12Labeling · Supplement 7AP
1995-08-22Manufacturing (CMC) · Supplement 6AP
1994-09-30Manufacturing (CMC) · Supplement 3AP
1994-06-10Manufacturing (CMC) · Supplement 4AP
1994-05-05Labeling · Supplement 5AP
1993-08-19Labeling · Supplement 2AP
1984-03-30OriginalAP
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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