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FDA ANDA · ANDA078107
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: HIKMA
APPLICATION
ANDA078107
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-30
LATEST ACTION
2020-12-07
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 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2020-12-07Labeling · Supplement 4 · standardAP
2020-12-07Labeling · Supplement 5 · standardAP
2012-03-28Labeling · Supplement 3AP
2012-03-20Labeling · Supplement 2AP
2008-07-30OriginalAP
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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