APPLICATION
ANDA087102
TYPE
ANDA
ORIGINAL APPROVAL
1982-04-27
LATEST ACTION
1996-07-31
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
FLUOCINOLONE ACETONIDEDiscontinued
FLUOCINOLONE ACETONIDE 0.01% · CREAM · TOPICAL
Approval history
1996-07-31Labeling · Supplement 29AP
1993-03-29Labeling · Supplement 28AP
1993-03-29Labeling · Supplement 27AP
1992-11-16Labeling · Supplement 26AP
1992-03-13Manufacturing (CMC) · Supplement 19AP
1991-03-15Labeling · Supplement 24AP
1991-01-07Labeling · Supplement 23AP
1990-01-03Manufacturing (CMC) · Supplement 20AP
1989-09-19Labeling · Supplement 21AP
1988-11-25Labeling · Supplement 18AP
1986-10-07Manufacturing (CMC) · Supplement 12AP
1986-01-10Manufacturing (CMC) · Supplement 10AP
1984-06-12Manufacturing (CMC) · Supplement 6AP
1984-03-29Manufacturing (CMC) · Supplement 5AP
1983-06-15Manufacturing (CMC) · Supplement 4AP
1983-01-03Manufacturing (CMC) · Supplement 3AP
1982-04-27OriginalAP
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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