APPLICATION
ANDA077431
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-01
LATEST ACTION
2025-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EXEMESTANEDiscontinued
EXEMESTANE 25MG · TABLET · ORAL
Approval history
2025-10-07Labeling · Supplement 12 · standardAP
2022-06-15Labeling · Supplement 10 · standardAP
2020-08-13Labeling · Supplement 9 · standardAP
2020-08-13Labeling · Supplement 8 · standardAP
2015-07-06Labeling · Supplement 4 · standardAP
2015-07-06Labeling · Supplement 3 · standardAP
2011-08-03Labeling · Supplement 1AP
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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