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FDA ANDA · ANDA203378
FLUOCINOLONE ACETONIDE OIL
fluocinolone acetonide
Sponsor: RISING
APPLICATION
ANDA203378
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-25
LATEST ACTION
2025-07-18
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
OIL/DROPS
MARKETING STATUS
Prescription
Products
FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.01% · OIL/DROPS · OTIC
Approval history
2025-07-18Labeling · Supplement 3 · standardAP
2022-05-31Labeling · Supplement 1 · 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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