Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/09/2000 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21107ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21107a_Lotronex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/07/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021107s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021107Orig1s027ltr.pdf
01/07/2016 SUPPL-26 REMS-Modified Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021107Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021107Orig1s026.pdf
07/24/2015 SUPPL-25 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021107Orig1s025ltr.pdf
05/08/2014 SUPPL-24 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021107Orig1s024ltr.pdf
04/19/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/02/2010 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021107s016ltr.pdf
09/02/2010 SUPPL-14 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021107s014ltr.pdf
04/01/2008 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021107s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021107s013ltr.pdf
03/10/2006 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021107s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021107s012ltr.pdf
02/18/2005 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21107s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21107s011ltr.pdf
02/04/2005 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021107s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21107s010ltr.pdf
01/31/2005 SUPPL-9 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

12/23/2003 SUPPL-8 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21107scf008_lotronex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107scf008ltr.pdf
03/20/2003 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107slr007ltr.pdf
06/03/2002 SUPPL-6 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S006_LOTRONEX_TABLETS.pdf
06/07/2002 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21107s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21107s5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S005_LOTRONEX_TABLETS.pdf
08/11/2000 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S002_LOTRONEX_TABLET.pdf
03/07/2000 SUPPL-1 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S001_LOTRONEX_TABLET.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.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-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

LOTRONEX

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 206647 AMNEAL PHARMS
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 200652 WEST-WARD PHARMS INT
LOTRONEX ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription Yes AB 021107 SEBELA IRELAND LTD

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 206647 AMNEAL PHARMS
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 200652 WEST-WARD PHARMS INT
LOTRONEX ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription Yes AB 021107 SEBELA IRELAND LTD

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