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FDA ANDA · ANDA090982
FLUOCINOLONE ACETONIDE OIL
fluocinolone acetonide
Sponsor: RISING
APPLICATION
ANDA090982
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-25
LATEST ACTION
2025-09-16
ROUTE
TOPICAL
DOSAGE FORM
OIL
MARKETING STATUS
Prescription
Products
FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.01% · OIL · TOPICAL
Approval history
2025-09-16Labeling · Supplement 2 · 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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