APPLICATION
ANDA090305
TYPE
ANDA
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)
Products
LEVOFLOXACIN; DEXTROSENone (Tentative Approval)
LEVOFLOXACIN 5% (5MG/ML), DEXTROSE · INJECTABLE · INJECTION
Approval history
2010-12-01OriginalTA
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.