APPLICATION
ANDA202847
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-09
LATEST ACTION
2025-09-03
ROUTE
TOPICAL
DOSAGE FORM
OIL
MARKETING STATUS
Prescription
Products
FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.01% · OIL · TOPICAL
Approval history
2025-09-03Labeling · Supplement 13 · standardAP
2013-08-09UNKNOWN · OriginalAP
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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