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FDA NDA · NDA021445

ZETIA

ezetimibe

Sponsor: ORGANON

APPLICATION
NDA021445
TYPE
NDA
ORIGINAL APPROVAL
2002-10-25
LATEST ACTION
2024-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZETIA · ReferencePrescription
EZETIMIBE 10MG · TABLET · ORAL

Approval history

2024-02-21Labeling · Supplement 43 · standard — Letter ↗AP
2023-07-20Labeling · Supplement 42 · standard — Letter ↗AP
2019-10-03Labeling · Supplement 40 · standard — Label ↗AP
2014-09-30Labeling · Supplement 37 · unknown — Letter ↗AP
2013-06-04Manufacturing (CMC) · Supplement 36 · standardAP
2013-02-15Manufacturing (CMC) · Supplement 35 · standardAP
2013-01-11Manufacturing (CMC) · Supplement 34 · standardAP
2012-01-24Efficacy · Supplement 33 · standard — Label ↗AP
2011-07-29Efficacy · Supplement 30 · standard — Letter ↗AP
2009-07-21Labeling · Supplement 26 · standard — Letter ↗AP
2009-07-21Labeling · Supplement 27 · standard — Label ↗AP
2009-01-27Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2008-06-05Efficacy · Supplement 20 · priority — Label ↗AP
2008-06-05Labeling · Supplement 21 · standard — Letter ↗AP
2008-02-07Labeling · Supplement 19 · standard — Letter ↗AP
2007-12-10Labeling · Supplement 18 · standard — Label ↗AP
2007-12-10Manufacturing (CMC) · Supplement 2 · standardAP
2006-11-02Labeling · Supplement 16 · standard — Letter ↗AP
2006-05-23Efficacy · Supplement 13 · standard — Label ↗AP
2006-03-16Efficacy · Supplement 12 · unknown — Letter ↗AP
2006-03-16Labeling · Supplement 15 · standard — Letter ↗AP
2006-01-19Labeling · Supplement 14 · standard — Label ↗AP
2005-03-22Labeling · Supplement 11 · standard — Letter ↗AP
2005-03-02Labeling · Supplement 7 · standard — Letter ↗AP
2004-09-22Labeling · Supplement 6 · standard — Letter ↗AP
2004-07-23Labeling · Supplement 1 · standard — Label ↗AP
2004-07-23Labeling · Supplement 4 · standard — Label ↗AP
2004-07-23Labeling · Supplement 3 · standard — Review ↗AP
2002-10-25Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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