Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021372
Company: HELSINN HLTHCARE
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) INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
ALOXI PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

ALOXI

INJECTABLE;INTRAVENOUS; EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOXI PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021372 HELSINN HLTHCARE
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 201533 DR REDDYS LABS LTD
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 202521 SANDOZ INC

INJECTABLE;INTRAVENOUS; EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOXI PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021372 HELSINN HLTHCARE
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 201533 DR REDDYS LABS LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English