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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205718
Company: HELSINN HLTHCARE

Summary Review

Products on NDA 205718

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AKYNZEO	NETUPITANT; PALONOSETRON HYDROCHLORIDE	300MG;EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205718

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2014	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205718Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205718s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205718Orig1s009ltr.pdf
12/28/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/12/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/20/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/13/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/27/2015	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205718Orig1s003ltr.pdf
04/29/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf
02/16/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205718

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205718s009lbl.pdf
04/29/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf
04/27/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718Orig1s003lbl.pdf
10/10/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf

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