Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022233
Company: HELSINN HLTHCARE
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ALOXI PALONOSETRON HYDROCHLORIDE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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