Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021892
Company: SALIX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSMOPREP SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.398GM;1.102GM TABLET;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
03/16/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021892s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021892s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021892_osmoprep_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/29/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021892s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021892Orig1s014ltr.pdf
06/21/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/15/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/09/2011 SUPPL-9 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021892s009,021097s015ltr.pdf
10/05/2012 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021892Orig1s006ltr.pdf
10/13/2009 SUPPL-4 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s014,021892s004ltr.pdf
03/25/2009 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021892s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s013,021892s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021892Orig1s003.pdf
12/10/2008 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021892s002ltr.pdf
09/18/2007 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021892s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/29/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021892s014lbl.pdf
10/05/2012 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006lbl.pdf
10/13/2009 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf
10/13/2009 SUPPL-4 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf
03/25/2009 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021892s003lbl.pdf
03/16/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021892s000lbl.pdf

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