APPLICATION
ANDA210323
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-27
LATEST ACTION
2025-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EXEMESTANEPrescription
EXEMESTANE 25MG · TABLET · ORAL
Approval history
2025-07-01Labeling · Supplement 8 · standardAP
2022-06-15Labeling · Supplement 5 · standardAP
2019-02-22Labeling · Supplement 1 · standardAP
2018-04-27UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.