APPLICATION
ANDA079104
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-30
LATEST ACTION
2025-01-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
FLUCONAZOLE 400MG/200ML (2MG/ML) · INJECTABLE · INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2025-01-14Labeling · Supplement 19 · standardAP
2025-01-14Labeling · Supplement 17 · standardAP
2025-01-14Labeling · Supplement 24 · standardAP
2025-01-14Labeling · Supplement 22 · standardAP
2025-01-14Labeling · Supplement 20 · standardAP
2025-01-14Labeling · Supplement 12 · standardAP
2015-03-14Labeling · Supplement 7 · standardAP
2015-03-14Labeling · Supplement 8 · standardAP
2012-03-14Labeling · Supplement 5AP
2012-01-31Labeling · Supplement 1AP
2012-01-31Labeling · Supplement 2AP
2009-07-30OriginalAP
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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