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FDA ANDA · ANDA203796

LETROZOLE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA203796
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-03
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LETROZOLEDiscontinued
LETROZOLE 2.5MG · TABLET · ORAL

Approval history

2025-10-24Labeling · Supplement 2 · standardAP
2024-03-06Labeling · Supplement 1 · standardAP
2016-06-03UNKNOWN · OriginalAP
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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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