APPLICATION
ANDA211815
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-14
LATEST ACTION
2025-01-24
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
OIL/DROPS
MARKETING STATUS
Discontinued
Products
FLUOCINONIDE ACETONIDEDiscontinued
FLUOCINOLONE ACETONIDE 0.01% · OIL/DROPS · OTIC
Approval history
2025-01-24Labeling · Supplement 4 · standardAP
2018-12-14UNKNOWN · 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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