← FDA DRUG APPROVALS

FDA NDA · NDA020541

ARIMIDEX

anastrozole

Sponsor: ANI PHARMS

APPLICATION
NDA020541
TYPE
NDA
ORIGINAL APPROVAL
1995-12-27
LATEST ACTION
2024-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ARIMIDEX · ReferencePrescription
ANASTROZOLE 1MG · TABLET · ORAL

Approval history

2024-12-16Labeling · Supplement 36 · standard — Label ↗AP
2018-12-13Labeling · Supplement 31 · standard — Letter ↗AP
2014-05-02Labeling · Supplement 29 — Label ↗AP
2013-05-01Labeling · Supplement 27 · standard — Review ↗AP
2011-04-18Efficacy · Supplement 26 · standard — Label ↗AP
2009-04-30Efficacy · Supplement 24 · unknown — Label ↗AP
2009-04-30Labeling · Supplement 25 · standard — Label ↗AP
2008-12-10Labeling · Supplement 20 · standard — Review ↗AP
2008-12-10Labeling · Supplement 23 · standard — Review ↗AP
2008-12-10Labeling · Supplement 21 · standard — Review ↗AP
2006-05-10Manufacturing (CMC) · Supplement 18AP
2005-09-16Efficacy · Supplement 16 · unknown — Label ↗AP
2004-08-30Labeling · Supplement 15 · standard — Letter ↗AP
2002-10-07Labeling · Supplement 5 · standard — Letter ↗AP
2002-09-05Efficacy · Supplement 10 · priority — Review ↗AP
2001-09-10Manufacturing (CMC) · Supplement 8 · standardAP
2001-08-02Manufacturing (CMC) · Supplement 7 · standardAP
2000-09-01Efficacy · Supplement 6 · standard — Review ↗AP
1998-08-13Manufacturing (CMC) · Supplement 4 · standardAP
1998-02-06Labeling · Supplement 2 · standardAP
1997-09-19Labeling · Supplement 3 · standardAP
1996-10-18Labeling · Supplement 1 · standardAP
1995-12-27Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →