APPLICATION
ANDA215574
TYPE
ANDA
ORIGINAL APPROVAL
2024-02-13
LATEST ACTION
2025-07-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OSPEMIFENEDiscontinued
OSPEMIFENE 60MG · TABLET · ORAL
Approval history
2025-07-25Labeling · Supplement 2 · standardAP
2024-07-24Labeling · Supplement 1 · 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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