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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021097
Company: SALIX PHARMS

Medication Guide

Other Important Information from FDA

Products on NDA 021097

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021097

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.

Labels for NDA 021097

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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