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FDA ANDA · ANDA078485

ANASTROZOLE

Sponsor: HIKMA

APPLICATION
ANDA078485
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-28
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ANASTROZOLEDiscontinued
ANASTROZOLE 1MG · TABLET · ORAL

Approval history

2025-10-24Labeling · Supplement 9 · standardAP
2025-02-21Labeling · Supplement 8 · standardAP
2015-11-05Labeling · Supplement 7 · standardAP
2015-11-05Labeling · Supplement 6 · standardAP
2011-11-14Labeling · Supplement 2AP
2010-06-28OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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