APPLICATION
ANDA062427
TYPE
ANDA
ORIGINAL APPROVAL
1983-05-26
LATEST ACTION
1996-07-05
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
GENTAMICIN SULFATEDiscontinued
GENTAMICIN SULFATE EQ 0.1% BASE · CREAM · TOPICAL
Approval history
1996-07-05Manufacturing (CMC) · Supplement 38AP
1996-07-05Labeling · Supplement 39AP
1992-09-16Labeling · Supplement 37AP
1992-08-27Labeling · Supplement 36AP
1992-06-26Labeling · Supplement 34AP
1992-04-22Labeling · Supplement 33AP
1991-07-30Manufacturing (CMC) · Supplement 30AP
1991-04-26Labeling · Supplement 32AP
1991-04-15Labeling · Supplement 29AP
1991-04-15Labeling · Supplement 27AP
1989-07-24Manufacturing (CMC) · Supplement 28AP
1988-11-16Manufacturing (CMC) · Supplement 26AP
1987-07-09Manufacturing (CMC) · Supplement 24AP
1986-07-03Manufacturing (CMC) · Supplement 23AP
1986-02-14Manufacturing (CMC) · Supplement 22AP
1986-02-10Manufacturing (CMC) · Supplement 21AP
1985-11-25Manufacturing (CMC) · Supplement 20AP
1985-09-16Manufacturing (CMC) · Supplement 19AP
1985-05-20Manufacturing (CMC) · Supplement 18AP
1983-05-26OriginalAP
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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