Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208745
Company: SALIX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRULANCE PLECANATIDE 3MG TABLET;ORAL 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
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
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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