APPLICATION
ANDA202849
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-17
LATEST ACTION
2025-10-01
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
OIL/DROPS
MARKETING STATUS
Prescription
Products
FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.01% · OIL/DROPS · OTIC
Approval history
2025-10-01Labeling · Supplement 4 · standardAP
2017-07-17UNKNOWN · 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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