APPLICATION
ANDA090268
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-20
LATEST ACTION
2017-02-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2017-02-07Labeling · Supplement 3 · standardAP
2010-12-20OriginalAP
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.