APPLICATION
ANDA088167
TYPE
ANDA
ORIGINAL APPROVAL
1982-12-16
LATEST ACTION
2005-04-11
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.01% · SOLUTION · TOPICAL
Approval history
2005-04-11Labeling · Supplement 6AP
1996-06-24Manufacturing (CMC) · Supplement 5AP
1988-03-09Manufacturing (CMC) · Supplement 3AP
1982-12-16OriginalAP
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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