APPLICATION
ANDA200654
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-11
LATEST ACTION
2025-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ANASTROZOLEDiscontinued
ANASTROZOLE 1MG · TABLET · ORAL
Approval history
2025-07-08Labeling · Supplement 4 · standardAP
2025-07-08Labeling · Supplement 5 · standardAP
2016-01-12Labeling · Supplement 2 · standardAP
2016-01-12Labeling · Supplement 1 · standardAP
2012-05-11Not Applicable · OriginalAP
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.