APPLICATION
ANDA076087
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2020-11-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%Prescription
FLUCONAZOLE 400MG/200ML (2MG/ML) · INJECTABLE · INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%Prescription
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%Prescription
FLUCONAZOLE 100MG/50ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2020-11-27Labeling · Supplement 15 · standardAP
2020-11-27Labeling · Supplement 16 · standardAP
2012-03-14Labeling · Supplement 13AP
2012-01-30Labeling · Supplement 10AP
2012-01-30Labeling · Supplement 8AP
2008-12-01Labeling · Supplement 6AP
2008-09-26Labeling · Supplement 4AP
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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