APPLICATION
ANDA076766
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2024-07-16
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
2024-07-16Labeling · Supplement 17 · standardAP
2024-02-16Labeling · Supplement 16 · standardAP
2023-07-14Labeling · Supplement 14 · standardAP
2022-08-09Labeling · Supplement 12 · standardAP
2022-08-09Labeling · Supplement 10 · standardAP
2015-03-14Labeling · Supplement 8 · standardAP
2013-06-04Labeling · Supplement 7 · standardAP
2009-01-14Labeling · Supplement 5AP
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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