← FDA DRUG APPROVALS

FDA NDA · NDA021687

VYTORIN

ezetimibe and simvastatin

Sponsor: ORGANON

APPLICATION
NDA021687
TYPE
NDA
ORIGINAL APPROVAL
2004-07-23
LATEST ACTION
2024-03-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VYTORIN · ReferencePrescription
EZETIMIBE 10MG, SIMVASTATIN 80MG · TABLET · ORAL
VYTORIN · ReferencePrescription
EZETIMIBE 10MG, SIMVASTATIN 20MG · TABLET · ORAL
VYTORIN · ReferencePrescription
EZETIMIBE 10MG, SIMVASTATIN 40MG · TABLET · ORAL
VYTORIN · ReferencePrescription
EZETIMIBE 10MG, SIMVASTATIN 10MG · TABLET · ORAL

Approval history

2024-03-28Labeling · Supplement 66 · standard — Label ↗AP
2024-02-08Labeling · Supplement 64 · standard — Label ↗AP
2024-02-08Labeling · Supplement 65 · standard — Label ↗AP
2024-02-08Labeling · Supplement 61 · standard — Letter ↗AP
2020-09-25Labeling · Supplement 63 · 901 required — Letter ↗AP
2019-10-04Labeling · Supplement 62 · standard — Letter ↗AP
2019-04-02Labeling · Supplement 52 · standard — Label ↗AP
2018-02-28Labeling · Supplement 60 · standard — Label ↗AP
2017-01-19Manufacturing (CMC) · Supplement 57 · standard — Review ↗AP
2015-02-02Labeling · Supplement 53 · standard — Label ↗AP
2014-09-30Labeling · Supplement 51 · unknown — Letter ↗AP
2014-02-27Labeling · Supplement 50 · standard — Label ↗AP
2013-10-25Labeling · Supplement 48 · standard — Label ↗AP
2012-10-31Labeling · Supplement 46 · standard — Letter ↗AP
2012-10-31Labeling · Supplement 47 · 901 required — Label ↗AP
2012-02-28Labeling · Supplement 44 · unknown — Letter ↗AP
2012-01-24Efficacy · Supplement 39 · standard — Label ↗AP
2011-12-01Labeling · Supplement 42 · unknown — Label ↗AP
2011-10-06Labeling · Supplement 41 · unknown — Review ↗AP
2011-06-08Labeling · Supplement 33 · unknown — Letter ↗AP
2011-06-08Labeling · Supplement 40 · 901 required — Label ↗AP
2010-12-22Labeling · Supplement 37 · unknown — Label ↗AP
2010-04-22Labeling · Supplement 36 · unknown — Label ↗AP
2010-03-10Labeling · Supplement 34 · unknown — Label ↗AP
2009-11-06Labeling · Supplement 32 · standard — Label ↗AP
2009-01-30Labeling · Supplement 30 · standard — Letter ↗AP
2009-01-08Labeling · Supplement 29 · standard — Label ↗AP
2008-06-13Labeling · Supplement 25 · standardAP
2008-06-13Efficacy · Supplement 23 · priorityAP
2008-02-08Labeling · Supplement 22 · standard — Label ↗AP
2007-12-12Labeling · Supplement 21 · standard — Label ↗AP
2007-05-16Labeling · Supplement 19 · standard — Letter ↗AP
2006-11-27Manufacturing (CMC) · Supplement 16 — Label ↗AP
2006-10-24Labeling · Supplement 10 · standard — Label ↗AP
2006-10-03Efficacy · Supplement 11 · unknown — Label ↗AP
2006-07-03Labeling · Supplement 15 · standard — Letter ↗AP
2006-03-16Efficacy · Supplement 6 · unknown — Label ↗AP
2006-03-16Labeling · Supplement 13 · standard — Letter ↗AP
2005-12-09Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2005-10-19Labeling · Supplement 4 · standard — Label ↗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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