APPLICATION
ANDA076104
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-28
LATEST ACTION
2025-06-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ITRACONAZOLEPrescription
ITRACONAZOLE 100MG · CAPSULE · ORAL
Approval history
2025-06-09Labeling · Supplement 28 · standardAP
2024-10-24Labeling · Supplement 27 · standardAP
2024-10-24Labeling · Supplement 25 · standardAP
2023-05-26Labeling · Supplement 24 · standardAP
2019-10-09Labeling · Supplement 21 · standardAP
2019-10-09Labeling · Supplement 22 · standardAP
2019-10-09Labeling · Supplement 20 · standardAP
2019-10-09Labeling · Supplement 19 · standardAP
2015-11-17Labeling · Supplement 18 · standardAP
2015-11-17Labeling · Supplement 16 · standardAP
2013-02-20Labeling · Supplement 11 · standardAP
2012-03-29Labeling · Supplement 10AP
2011-01-12Labeling · Supplement 9AP
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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