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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207865
Company: MSD MERCK CO

Products on NDA 207865

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMEND	APREPITANT	125MG/KIT	FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207865

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2015	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207865lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207865Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207865Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2019	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s031,207865s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021549Orig1s031,%20207865Orig1s004ltr.pdf
11/14/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s030,207865s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021549Orig1s030, 022023Orig1s019, 207865Orig1s003ltr.pdf
05/31/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021549s027,207865s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021549Orig1s027,207865Orig1s001ltr.pdf

Labels for NDA 207865

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s030,207865s003lbl.pdf
09/25/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s031,207865s004lbl.pdf
09/25/2019	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s031,207865s004lbl.pdf
05/31/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021549s027,207865s001lbl.pdf
12/17/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207865lbl.pdf

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