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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022023
Company: MERCK AND CO INC

Products on NDA 022023

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EMEND	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER;INTRAVENOUS	Discontinued	None	Yes	No
EMEND	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022023

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
05/02/2022	SUPPL-21	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022023s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022023Orig1s021ltr.pdf
11/14/2019	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022023s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021549Orig1s030, 022023Orig1s019, 207865Orig1s003ltr.pdf
03/26/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022023Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022023Orig1s018.pdf
04/03/2018	SUPPL-17	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022023s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022023Orig1s017.pdf
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) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022023Orig1s014.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-Patient Package Insert, Labeling-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.

Labels for NDA 022023

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/02/2022	SUPPL-21	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022023s021lbl.pdf
11/14/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022023s019lbl.pdf
04/03/2018	SUPPL-17	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s017lbl.pdf
03/26/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s018lbl.pdf
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-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
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

Therapeutic Equivalents for NDA 022023

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	214616	ASPIRO
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211860	BAXTER HLTHCARE CORP
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212309	BE PHARMS
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212143	CHIA TAI TIANQING
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211160	DR REDDYS
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	210625	EUGIA PHARMA
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206197	FRESENIUS KABI USA
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	210689	LUPIN LTD
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	209965	MSN
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	204015	MYLAN LABS LTD
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214683	PIRAMAL CRITICAL
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213106	QILU PHARM HAINAN

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