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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021892
Company: SALIX PHARMS

Medication Guide

Products on NDA 021892

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	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021892

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	REMS-Proposal, Labeling	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

Labels for NDA 021892

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	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf
10/13/2009	SUPPL-4	Labeling	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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