APPLICATION
ANDA062501
TYPE
ANDA
ORIGINAL APPROVAL
1984-07-26
LATEST ACTION
1997-12-09
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
GENTACIDINDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE · OINTMENT · OPHTHALMIC
Approval history
1997-12-09Manufacturing (CMC) · Supplement 2AP
1996-07-03Manufacturing (CMC) · Supplement 5AP
1996-07-03Manufacturing (CMC) · Supplement 4AP
1995-12-15Manufacturing (CMC) · Supplement 3AP
1992-06-12Labeling · Supplement 1AP
1984-07-26OriginalAP
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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