Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021097
Company: SALIX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VISICOL SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.398GM;1.102GM TABLET;ORAL Discontinued None No 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
09/21/2000 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21097ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21097_Visicol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/07/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021097s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021097Orig1s016ltr.pdf
12/09/2011 SUPPL-15 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021892s009,021097s015ltr.pdf
10/13/2009 SUPPL-14 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021097Orig1s014.pdf
03/25/2009 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s013,021892s003ltr.pdf
03/31/2006 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021097s10lblM.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021097s010ltr.pdf
02/10/2005 SUPPL-9 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21097s007,009ltr.pdf
02/10/2005 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21097s007,009ltr.pdf
09/04/2002 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/2002 SUPPL-5 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21097s005ltr.pdf
09/26/2001 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/30/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2001 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/22/2000 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/07/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021097s016lbl.pdf
10/13/2009 SUPPL-14 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf
10/13/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf
03/25/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s013lbl.pdf
03/31/2006 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021097s10lblM.pdf
09/21/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21097lbl.pdf

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