APPLICATION
ANDA212239
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-01
LATEST ACTION
2025-03-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ITRACONAZOLEPrescription
ITRACONAZOLE 10MG/ML · SOLUTION · ORAL
Approval history
2025-03-28Labeling · Supplement 5 · standardAP
2025-01-29Labeling · Supplement 4 · standardAP
2025-01-29Labeling · Supplement 2 · standardAP
2023-05-26Labeling · Supplement 1 · standardAP
2020-09-01UNKNOWN · 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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