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FDA ANDA · ANDA077909
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: WOODWARD
APPLICATION
ANDA077909
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-26
LATEST ACTION
2015-04-20
ROUTE
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 100MG/50ML (2MG/ML) · INJECTABLE · INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2015-04-20Manufacturing (CMC) · Supplement 6 · unknownAP
2014-11-10Labeling · Supplement 4 · standardAP
2014-11-10Labeling · Supplement 3 · standardAP
2010-05-26OriginalAP
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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