APPLICATION
ANDA208481
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-02
LATEST ACTION
2025-06-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ITRACONAZOLEDiscontinued
ITRACONAZOLE 10MG/ML · SOLUTION · ORAL
Approval history
2025-06-16Labeling · Supplement 3 · standardAP
2025-06-16Labeling · Supplement 4 · standardAP
2024-09-30Labeling · Supplement 1 · standardAP
2024-09-30Labeling · Supplement 2 · standardAP
2019-08-02UNKNOWN · 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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