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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022246
Company: SALIX PHARMS

Medication Guide

Summary Review

Products on NDA 022246

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOZOLV ODT	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
METOZOLV ODT	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022246

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022246s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022246s000ltr .pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022246_metozolv_odt_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022246s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2019	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022246s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022246Orig1s009ltr.pdf
09/27/2011	SUPPL-6	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022246s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022246s006ltr.pdf
08/22/2011	SUPPL-5	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022246s005ltr.pdf
08/22/2011	SUPPL-4			Label is not available on this site.
11/18/2010	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022246s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022246s001ltr.pdf

Labels for NDA 022246

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022246s009lbl.pdf
02/28/2019	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022246s009lbl.pdf
09/27/2011	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022246s006lbl.pdf
11/18/2010	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022246s001lbl.pdf
09/04/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022246s000lbl.pdf

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