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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021107
Company: SEBELA IRELAND LTD

Medication Guide

Other Important Information from FDA

REMS

Products on NDA 21107

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

Labels for NDA 021107

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-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

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