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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208745
Company: SALIX

Medication Guide

Products on NDA 208745

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRULANCE	PLECANATIDE	3MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208745

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/19/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208745lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208745Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208745Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/13/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208745Orig1s011ltr.pdf
10/29/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208745s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208745Orig1s010ltr.pdf
02/10/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208745Orig1s007ltr.pdf
07/25/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208745Orig1s002Ltr.pdf
01/24/2018	SUPPL-1	Efficacy-Manufacturing Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208745Orig1s001ltr.pdf

Labels for NDA 208745

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/13/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf
02/10/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s007lbl.pdf
10/29/2020	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208745s010lbl.pdf
10/29/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208745s010lbl.pdf
07/25/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s002lbl.pdf
01/24/2018	SUPPL-1	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s001lbl.pdf
01/19/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208745lbl.pdf

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