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FDA NDA · NDA020726

FEMARA

letrozole

Sponsor: NOVARTIS PHARMS

APPLICATION
NDA020726
TYPE
NDA
ORIGINAL APPROVAL
1997-07-25
LATEST ACTION
2024-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FEMARA · ReferencePrescription
LETROZOLE 2.5MG · TABLET · ORAL

Approval history

2024-12-16Labeling · Supplement 43 · standard — Label ↗AP
2018-04-05Labeling · Supplement 35 · standard — Letter ↗AP
2017-07-13Labeling · Supplement 33 · standard — Letter ↗AP
2016-10-28Manufacturing (CMC) · Supplement 30 · standardAP
2015-12-23Manufacturing (CMC) · Supplement 29 · standardAP
2014-01-15Labeling · Supplement 27 · standard — Label ↗AP
2013-07-11Manufacturing (CMC) · Supplement 25 · standardAP
2011-12-23Labeling · Supplement 24 · standard — Letter ↗AP
2010-06-25Labeling · Supplement 19 · standard — Label ↗AP
2010-04-30Efficacy · Supplement 20 · standard — Letter ↗AP
2010-03-02Efficacy · Supplement 16 · unknown — Label ↗AP
2010-03-02Efficacy · Supplement 15 · unknown — Label ↗AP
2009-07-07Labeling · Supplement 18 · standard — Letter ↗AP
2008-08-07Labeling · Supplement 17 · standard — Letter ↗AP
2007-04-11Labeling · Supplement 14 · standard — Letter ↗AP
2006-06-26Labeling · Supplement 13 · standard — Letter ↗AP
2005-12-28Efficacy · Supplement 12 · priority — Label ↗AP
2004-10-29Efficacy · Supplement 11 · unknown — Label ↗AP
2003-02-26Efficacy · Supplement 5 · standard — Label ↗AP
2003-01-17Efficacy · Supplement 8 · standard — Letter ↗AP
2002-01-10Manufacturing (CMC) · Supplement 7 · standardAP
2001-02-05Manufacturing (CMC) · Supplement 3 · standardAP
2001-01-10Efficacy · Supplement 6 · priority — Label ↗AP
2000-05-23Manufacturing (CMC) · Supplement 4 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 2 · standardAP
1999-03-17Manufacturing (CMC) · Supplement 1 · standardAP
1997-07-25Type 1 - New Molecular Entity · Original · standard — Review ↗AP
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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