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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 021881

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021881

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021881lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021881s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021881_moviprep_toc.cfm

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021881Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021881Orig1s024ltr.pdf
05/14/2021	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021881s023lbl.pdf
11/05/2019	SUPPL-20	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021881Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021881Orig1s020ltr.pdf
12/07/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021881s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021881Orig1s017Ltr.pdf
12/17/2013	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021881s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021881Orig1s016ltr.pdf
09/12/2013	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021881s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021881Orig1s015ltr.pdf
08/29/2012	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021881s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021881Orig1s012ltr.pdf
11/02/2010	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021881s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021881s010ltr.pdf
04/28/2011	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021881s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021881s008ltr.pdf
11/20/2008	SUPPL-4	Labeling		Label is not available on this site.
02/05/2008	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021881s003ltr.pdf

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021881Orig1s020lbl.pdf
11/05/2019	SUPPL-20	Labeling-Container/Carton Labels	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

Therapeutic Equivalents for NDA 021881

MOVIPREP

FOR SOLUTION;ORAL; 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
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	Yes	AA	021881	SALIX PHARMS
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	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	No	AA	090145	NOVEL LABS INC
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	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	No	AA	207498	TARO

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