← FDA DRUG APPROVALS

FDA NDA · NDA022023

EMEND

fosaprepitant dimeglumine

Sponsor: MERCK AND CO INC

APPLICATION
NDA022023
TYPE
NDA
ORIGINAL APPROVAL
2008-01-25
LATEST ACTION
2022-05-02
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription, Discontinued

Products

EMEND · ReferencePrescription
FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL · POWDER · INTRAVENOUS
EMEND · ReferenceDiscontinued
FOSAPREPITANT DIMEGLUMINE EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS

Approval history

2022-05-02Efficacy · Supplement 21 · standard — Letter ↗AP
2019-11-14Labeling · Supplement 19 · standard — Letter ↗AP
2018-04-03Efficacy · Supplement 17 · priority — Label ↗AP
2018-03-26Labeling · Supplement 18 · standard — Label ↗AP
2017-08-09Labeling · Supplement 16 · standard — Letter ↗AP
2017-05-31Labeling · Supplement 15 · standard — Label ↗AP
2016-12-02Manufacturing (CMC) · Supplement 14 — Label ↗AP
2016-02-01Efficacy · Supplement 6 · standard — Label ↗AP
2015-01-12Manufacturing (CMC) · Supplement 12 · standardAP
2014-08-12Labeling · Supplement 11 · standard — Letter ↗AP
2013-03-27Labeling · Supplement 10 · standard — Label ↗AP
2013-03-20Labeling · Supplement 7 · standard — Label ↗AP
2012-07-06Labeling · Supplement 9 · standard — Letter ↗AP
2010-11-12Efficacy · Supplement 4 · standard — Review ↗AP
2010-03-23Labeling · Supplement 2 · standard — Label ↗AP
2010-03-23Labeling · Supplement 5 · unknown — Label ↗AP
2010-03-23Labeling · Supplement 3 · standard — Label ↗AP
2009-02-02Labeling · Supplement 1 · standardAP
2008-01-25Type 1 - New Molecular Entity · Original · standard — Pediatric Written Request ↗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 →