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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021964
Company: SALIX PHARMS

Medication Guide

Products on NDA 021964

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RELISTOR	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
RELISTOR	METHYLNALTREXONE BROMIDE	8MG/0.4ML (8MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	Yes	Yes
RELISTOR	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021964

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/24/2008	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021964s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021964s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/14/2018	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021964Orig1s019,208271Orig1s003ltr.pdf
08/01/2017	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s018;208271Orig1s002ltr.pdf
05/16/2017	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s017,208271s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s017,208271Orig1s001ltr.pdf
02/05/2016	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/09/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/20/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/30/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/23/2013	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021964s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021964Orig1s011ltr.pdf
09/29/2014	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021964s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021964Orig1s010ltr.pdf
07/23/2010	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021964s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021964s009ltr.pdf
09/27/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/04/2009	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021964s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021964s006ltr.pdf

Labels for NDA 021964

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/14/2018	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf
03/14/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf
08/01/2017	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf
08/01/2017	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf
05/16/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s017,208271s001lbl.pdf
09/29/2014	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021964s010lbl.pdf
08/23/2013	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021964s011lbl.pdf
07/23/2010	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021964s009lbl.pdf
11/04/2009	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021964s006lbl.pdf

Therapeutic Equivalents for NDA 021964

RELISTOR

SOLUTION;SUBCUTANEOUS; 8MG/0.4ML (8MG/0.4ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLNALTREXONE BROMIDE	METHYLNALTREXONE BROMIDE	8MG/0.4ML (8MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208112	ACTAVIS LLC
RELISTOR	METHYLNALTREXONE BROMIDE	8MG/0.4ML (8MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	021964	SALIX PHARMS

SOLUTION;SUBCUTANEOUS; 12MG/0.6ML (12MG/0.6ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLNALTREXONE BROMIDE	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208112	ACTAVIS LLC
RELISTOR	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	021964	SALIX PHARMS

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