APPLICATION
ANDA208591
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-12
LATEST ACTION
2025-03-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ITRACONAZOLEPrescription
ITRACONAZOLE 100MG · CAPSULE · ORAL
Approval history
2025-03-12Labeling · Supplement 14 · standardAP
2025-03-12Labeling · Supplement 13 · standardAP
2024-06-10Labeling · Supplement 10 · standardAP
2023-05-04Labeling · Supplement 9 · standardAP
2019-10-11Labeling · Supplement 4 · standardAP
2019-10-11Labeling · Supplement 2 · standardAP
2019-10-11Labeling · Supplement 3 · standardAP
2017-06-12UNKNOWN · 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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