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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021372
Company: HELSINN HLTHCARE

Summary Review

Products on NDA 021372

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No
ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021372

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2003	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21372_aloxi_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21372ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-372_Alox.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2020	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021372s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021372Orig1s021, 022233Orig1s006ltr.pdf
09/18/2014	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s020ltr.pdf
05/27/2014	SUPPL-19	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s018,s019ltr.pdf
05/27/2014	SUPPL-18	Efficacy-Pediatric	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s018,s019ltr.pdf
02/06/2014	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s017ltr.pdf
02/29/2008	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021372s008, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010_SumR.pdf
02/29/2008	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021372s008, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010_SumR.pdf
08/30/2007	SUPPL-6	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021372s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021372s006ltr.pdf
08/23/2006	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021372s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021372s005ltr.pdf
07/05/2005	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021372s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021372s002ltr.pdf

Labels for NDA 021372

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2020	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021372s021lbl.pdf
09/18/2014	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s020lbl.pdf
05/27/2014	SUPPL-19	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s018s019lbl.pdf
02/06/2014	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s017lbl.pdf
02/29/2008	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf
02/29/2008	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf
08/30/2007	SUPPL-6	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021372s006lbl.pdf
08/23/2006	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021372s005lbl.pdf
07/05/2005	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021372s002lbl.pdf
07/25/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21372_aloxi_lbl.pdf

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