Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022246
Company: SALIX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOZOLV ODT METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE 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ODT METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
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-Container/Carton Labels, Labeling-Package Insert 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2019 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022246s009lbl.pdf
02/28/2019 SUPPL-9 Labeling-Package Insert 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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