APPLICATION
ANDA076653
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2024-12-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%Discontinued
FLUCONAZOLE 400MG/200ML (2MG/ML) · INJECTABLE · INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%Discontinued
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2024-12-09Labeling · Supplement 24 · standardAP
2024-12-09Labeling · Supplement 22 · standardAP
2024-12-09Labeling · Supplement 25 · standardAP
2024-12-09Labeling · Supplement 23 · standardAP
2013-01-29Labeling · Supplement 13AP
2009-11-16Labeling · Supplement 3AP
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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