Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021881
Company: SALIX PHARMS
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 None Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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