APPLICATION
ANDA213454
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-01
LATEST ACTION
2023-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
POSACONAZOLEPrescription
POSACONAZOLE 100MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-12-18Labeling · Supplement 2 · standardAP
2023-12-18Labeling · Supplement 5 · standardAP
2023-12-18Labeling · Supplement 3 · standardAP
2023-12-18Labeling · Supplement 1 · standardAP
2021-02-01UNKNOWN · 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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