APPLICATION
ANDA205548
TYPE
ANDA
ORIGINAL APPROVAL
2020-08-10
LATEST ACTION
2025-07-09
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
CIPROFLOXACIN AND DEXAMETHASONEPrescription
CIPROFLOXACIN 0.3%, DEXAMETHASONE 0.1% · SUSPENSION/DROPS · OTIC
Approval history
2025-07-09Labeling · 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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