APPLICATION
ANDA090289
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-03
LATEST ACTION
2025-04-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LETROZOLEPrescription
LETROZOLE 2.5MG · TABLET · ORAL
Approval history
2025-04-22Labeling · Supplement 11 · standardAP
2021-06-22Manufacturing (CMC) · Supplement 9AP
2019-05-19Labeling · Supplement 5 · standardAP
2019-05-19Labeling · Supplement 4 · standardAP
2015-02-13Labeling · Supplement 3 · standardAP
2015-02-13Labeling · Supplement 2AP
2011-06-03OriginalAP
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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