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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021881
Company: SALIX PHARMS

Medication Guide

Products on NDA 21881

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOVIPREP	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION;ORAL	Prescription	AA	Yes	Yes

Labels for NDA 021881

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2022	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021881Orig1s024lbl.pdf
05/14/2021	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021881s023lbl.pdf
05/14/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021881s023lbl.pdf
11/05/2019	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021881Orig1s020lbl.pdf
11/05/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021881Orig1s020lbl.pdf
12/07/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021881s017lbl.pdf
12/17/2013	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021881s016lbl.pdf
09/12/2013	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021881s015lbl.pdf
08/29/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021881s012lbl.pdf
04/28/2011	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021881s008lbl.pdf
11/02/2010	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021881s010lbl.pdf
08/02/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021881lbl.pdf

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