APPLICATION
ANDA064093
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-31
LATEST ACTION
2017-03-10
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE · OINTMENT · OPHTHALMIC
Approval history
2017-03-10Manufacturing (CMC) · Supplement 11 · unknownAP
1999-04-27Manufacturing (CMC) · Supplement 3AP
1996-06-24Manufacturing (CMC) · Supplement 2AP
1995-12-28Manufacturing (CMC) · Supplement 1AP
1995-08-31OriginalAP
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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