APPLICATION
ANDA209336
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-19
LATEST ACTION
2026-06-24
ROUTE
TOPICAL
DOSAGE FORM
OIL
MARKETING STATUS
Prescription
Products
FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.01% · OIL · TOPICAL
Approval history
2026-06-24Labeling · Supplement 7 · standardAP
2016-05-19UNKNOWN · Original · standardAP
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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