APPLICATION
ANDA089124
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-11
LATEST ACTION
1996-07-31
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.01% · SOLUTION · TOPICAL
Approval history
1996-07-31Labeling · Supplement 15AP
1993-03-29Labeling · Supplement 14AP
1992-11-02Labeling · Supplement 13AP
1991-03-18Labeling · Supplement 12AP
1990-01-03Manufacturing (CMC) · Supplement 10AP
1989-05-11Manufacturing (CMC) · Supplement 8AP
1988-09-19Labeling · Supplement 6AP
1988-09-19Manufacturing (CMC) · Supplement 7AP
1986-10-07Manufacturing (CMC) · Supplement 4AP
1986-05-27Manufacturing (CMC) · Supplement 2AP
1985-09-11OriginalAP
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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