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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022233
Company: HELSINN HLTHCARE

Summary Review

Products on NDA 022233

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022233

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022233LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022233s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022233_aloxi_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022233s000Sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022233s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021372Orig1s021, 022233Orig1s006ltr.pdf
09/18/2014	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022233s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022233Orig1s005ltr.pdf

Labels for NDA 022233

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022233s006lbl.pdf
09/18/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022233s005lbl.pdf
08/22/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022233LBL.pdf

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