Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021964
Company: SALIX PHARMS
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 None Yes Yes
RELISTOR METHYLNALTREXONE BROMIDE 12MG/0.6ML (12MG/0.6ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
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-Package Insert, Labeling-Medication Guide 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf
08/01/2017 SUPPL-18 Labeling-Medication Guide 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

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