APPLICATION
ANDA076736
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-23
LATEST ACTION
2025-04-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%Prescription
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2025-04-25Labeling · Supplement 18 · standardAP
2025-04-25Labeling · Supplement 16 · standardAP
2025-04-25Labeling · Supplement 15 · standardAP
2015-03-19Labeling · Supplement 13 · standardAP
2012-01-25Labeling · Supplement 9AP
2010-11-30Labeling · Supplement 8AP
2008-08-29Labeling · Supplement 6AP
2005-08-23OriginalAP
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.