APPLICATION
ANDA205724
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-13
LATEST ACTION
2025-08-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ITRACONAZOLEPrescription
ITRACONAZOLE 100MG · CAPSULE · ORAL
Approval history
2025-08-15Labeling · Supplement 8 · standardAP
2025-08-15Labeling · Supplement 6 · standardAP
2025-08-15Labeling · Supplement 7 · standardAP
2023-05-26Labeling · Supplement 5 · standardAP
2019-11-12Labeling · Supplement 1 · standardAP
2019-11-12Labeling · Supplement 4 · standardAP
2019-11-12Labeling · Supplement 2 · standardAP
2016-12-13UNKNOWN · Original · standardAP
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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