APPLICATION
ANDA218434
TYPE
ANDA
ORIGINAL APPROVAL
2025-02-24
LATEST ACTION
2025-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
POSACONAZOLEPrescription
POSACONAZOLE 100MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2025-10-29Manufacturing (CMC) · Supplement 1 · unknownAP
2025-02-24UNKNOWN · 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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