U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021107
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTRONEX ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription AB Yes Yes
LOTRONEX ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/03/2019 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021107s029lbl.pdf
01/07/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021107s027lbl.pdf
09/02/2010 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf
09/02/2010 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf
09/02/2010 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s014lbl.pdf
09/02/2010 SUPPL-14 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s014lbl.pdf
04/01/2008 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021107s013lbl.pdf
03/10/2006 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021107s012lbl.pdf
02/18/2005 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21107s011lbl.pdf
02/04/2005 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021107s010lbl.pdf
12/23/2003 SUPPL-8 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21107scf008_lotronex_lbl.pdf
06/07/2002 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21107s5lbl.pdf
02/09/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21107lbl.pdf
Back to Top