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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210493
Company: HELSINN HLTHCARE

Products on NDA 210493

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AKYNZEO	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER;INTRAVENOUS	Discontinued	None	Yes	No
AKYNZEO	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE	EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210493

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2018	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210493s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210493Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210493Orig1s000ApprovTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2023	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210493Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210493Orig1s005ltr.pdf
06/02/2021	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210493s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210493Orig1s004ltr.pdf
10/27/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210493Orig1s003ltr.pdf
05/27/2020	SUPPL-2	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210493Orig1s002ltr.pdf
02/24/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for NDA 210493

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210493Orig1s005lbl.pdf
06/02/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210493s004lbl.pdf
10/27/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s003lbl.pdf
05/27/2020	SUPPL-2	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s002lbl.pdf
04/19/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210493s000lbl.pdf

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