APPLICATION
ANDA219475
TYPE
ANDA
ORIGINAL APPROVAL
2025-08-04
LATEST ACTION
2025-08-04
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
MOXIFLOXACIN HYDROCHLORIDEDiscontinued
MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2025-08-04UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.