APPLICATION
ANDA205080
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-26
LATEST ACTION
2025-03-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ITRACONAZOLEPrescription
ITRACONAZOLE 100MG · CAPSULE · ORAL
Approval history
2025-03-10Labeling · Supplement 18 · standardAP
2025-03-10Labeling · Supplement 17 · standardAP
2024-07-10Labeling · Supplement 16 · standardAP
2023-03-06Labeling · Supplement 12 · standardAP
2019-10-11Labeling · Supplement 3 · standardAP
2019-10-11Labeling · Supplement 1 · standardAP
2019-10-11Labeling · Supplement 4 · standardAP
2019-10-11Labeling · Supplement 2 · standardAP
2016-09-26UNKNOWN · 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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