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FDA ANDA · ANDA076304
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
ANDA076304
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2023-07-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
FLUCONAZOLE 400MG/200ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2023-07-17Labeling · Supplement 24 · standardAP
2023-07-17Labeling · Supplement 25 · standardAP
2021-05-12Labeling · Supplement 18 · standardAP
2021-05-12Labeling · Supplement 16 · standardAP
2021-05-12Labeling · Supplement 22 · standardAP
2021-05-12Labeling · Supplement 20 · standardAP
2021-05-12Labeling · Supplement 19 · standardAP
2021-05-12Labeling · Supplement 23 · standardAP
2014-03-24Labeling · Supplement 15 · standardAP
2008-08-25Labeling · Supplement 9AP
2006-05-11Labeling · 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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