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FDA ANDA · ANDA076303
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
ANDA076303
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2026-01-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
FLUCONAZOLE 400MG/200ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2026-01-14Labeling · Supplement 28 · standardAP
2023-07-17Labeling · Supplement 25 · standardAP
2023-07-17Labeling · Supplement 26 · standardAP
2021-05-12Labeling · Supplement 19 · standardAP
2021-05-12Labeling · Supplement 17 · standardAP
2021-05-12Labeling · Supplement 23 · standardAP
2021-05-12Labeling · Supplement 21 · standardAP
2021-05-12Labeling · Supplement 24 · standardAP
2021-05-12Labeling · Supplement 20 · standardAP
2014-03-24Labeling · Supplement 16 · standardAP
2008-08-25Labeling · Supplement 10AP
2006-05-11Labeling · Supplement 6AP
2006-03-23Labeling · 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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