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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209381
Company: SALIX

Medication Guide

Products on NDA 209381

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PLENVU	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	FOR SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209381

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2018	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209381s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209381Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209381Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209381s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209381Orig1s013ltr.pdf
05/14/2021	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209381s009lbledt02.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209381Orig1s009ltr.pdf
05/29/2019	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209381Orig1s002ltr.pdf
04/04/2019	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209381Orig1s001ltr.pdf

Labels for NDA 209381

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209381s013lbl.pdf
05/14/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209381s009lbledt02.pdf
05/14/2021	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209381s009lbledt02.pdf
05/14/2021	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209381s009lbledt02.pdf
05/29/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s002lbl.pdf
04/04/2019	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s001lbl.pdf
04/04/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s001lbl.pdf
05/04/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209381s000lbl.pdf

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