Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022023
Company: MERCK AND CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMEND FOSAPREPITANT DIMEGLUMINE EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** POWDER;INTRAVENOUS Discontinued None Yes No
EMEND FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/25/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022023s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/022023s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022023Orig1s016ltr.pdf
05/31/2017 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022023Orig1s015ltr.pdf
12/02/2016 SUPPL-14 Manufacturing (CMC)-Manufacturing Process Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s014lbl.pdf
01/12/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/12/2014 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022023s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021549Orig1s024,022023Orig1s011ltr.pdf
03/27/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s023,022023Orig1s010ltr.pdf
07/06/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022023s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022023Orig1s009ltr.pdf
03/20/2013 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022023Orig1s007ltr.pdf
02/01/2016 SUPPL-6 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s006lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022023Orig1s006ltr.pdf
03/23/2010 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf
11/12/2010 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022023Orig1s004.pdf
03/23/2010 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf
03/23/2010 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf
02/02/2009 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s016lbl.pdf
05/31/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s015lbl.pdf
12/02/2016 SUPPL-14 Manufacturing (CMC)-Manufacturing Process Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s014lbl.pdf
02/01/2016 SUPPL-6 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s006lbledt.pdf
08/12/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022023s011lbl.pdf
03/27/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s010lbl.pdf
03/20/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf
03/20/2013 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf
03/20/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf
07/06/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022023s009lbl.pdf
11/12/2010 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s004lbl.pdf
03/23/2010 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf
03/23/2010 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf
03/23/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf
01/25/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022023lbl.pdf

EMEND

POWDER;INTRAVENOUS; EQ 150MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMEND FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription Yes AP 022023 MERCK AND CO INC
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 206197 FRESENIUS KABI USA

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