APPLICATION
ANDA062477
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-23
LATEST ACTION
1996-07-05
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 0.1% BASE · OINTMENT · TOPICAL
Approval history
1996-07-05Manufacturing (CMC) · Supplement 23AP
1996-07-05Labeling · Supplement 24AP
1993-03-18Labeling · Supplement 22AP
1992-08-27Labeling · Supplement 21AP
1992-08-05Labeling · Supplement 20AP
1991-04-26Labeling · Supplement 19AP
1990-11-19Manufacturing (CMC) · Supplement 18AP
1989-06-30Manufacturing (CMC) · Supplement 17AP
1988-11-16Manufacturing (CMC) · Supplement 16AP
1983-12-23OriginalAP
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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