← FDA DRUG APPROVALS

FDA NDA · NDA021549

EMEND

aprepitant

Sponsor: MSD

APPLICATION
NDA021549
TYPE
NDA
ORIGINAL APPROVAL
2003-03-26
LATEST ACTION
2019-11-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

EMEND · ReferencePrescription
APREPITANT 125MG · CAPSULE · ORAL
EMEND · ReferenceDiscontinued
APREPITANT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
EMEND · ReferencePrescription
APREPITANT 80MG · CAPSULE · ORAL

Approval history

2019-11-14Labeling · Supplement 30 · standard — Letter ↗AP
2019-09-25Labeling · Supplement 31 · standard — Letter ↗AP
2017-05-31Labeling · Supplement 27 · standard — Label ↗AP
2015-08-28Efficacy · Supplement 25 · standard — Letter ↗AP
2015-01-12Manufacturing (CMC) · Supplement 26 · priorityAP
2014-08-12Labeling · Supplement 24 · standard — Label ↗AP
2013-03-27Labeling · Supplement 23 · standard — Letter ↗AP
2013-03-20Labeling · Supplement 19 · standard — Label ↗AP
2012-07-06Labeling · Supplement 21 · standard — Label ↗AP
2010-03-19Efficacy · Supplement 17 · standard — Letter ↗AP
2009-07-21Labeling · Supplement 14 · standard — Letter ↗AP
2009-02-02Labeling · Supplement 16 · standard — Letter ↗AP
2008-11-18Labeling · Supplement 15 · standard — Label ↗AP
2007-11-15Labeling · Supplement 12 · standard — Label ↗AP
2006-06-30Efficacy · Supplement 10 · unknown — Review ↗AP
2006-06-09Labeling · Supplement 11 · standard — Letter ↗AP
2005-10-28Efficacy · Supplement 8 · unknown — Label ↗AP
2005-06-09Labeling · Supplement 9 · standard — Letter ↗AP
2004-12-22Labeling · Supplement 7 · standard — Letter ↗AP
2004-12-15Labeling · Supplement 4 · standard — Label ↗AP
2004-01-15Labeling · Supplement 2 · standard — Letter ↗AP
2003-03-26Type 1 - New Molecular Entity · Original · priority — 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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