APPLICATION
ANDA091306
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-17
LATEST ACTION
2025-08-04
ROUTE
OTIC
DOSAGE FORM
OIL/DROPS
MARKETING STATUS
Discontinued
Products
FLUOCINOLONE ACETONIDEDiscontinued
FLUOCINOLONE ACETONIDE 0.01% · OIL/DROPS · OTIC
Approval history
2025-08-04Labeling · Supplement 9 · 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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