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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021692
Company: VALEANT PHARMS

Medication Guide

Products on NDA 021692

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULTRAM ER	TRAMADOL HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ULTRAM ER	TRAMADOL HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ULTRAM ER	TRAMADOL HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2005	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021692lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021692ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021692s000_RalivaTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021692s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021692Orig1s015ltr.pdf
12/16/2016	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021692s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021692Orig1s013,s014ltr.pdf
12/16/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021692s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021692Orig1s013,s014ltr.pdf
10/27/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/17/2009	SUPPL-9	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021692s009ltr.pdf
02/20/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021692s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021692s007ltr.pdf
02/20/2008	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021692s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021692s005ltr.pdf
08/03/2006	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021692s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021692s002LTR.pdf
06/05/2006	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021692s001LTR.pdf

Labels for NDA 021692

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021692s015lbl.pdf
12/16/2016	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021692s013s014lbl.pdf
12/16/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021692s013s014lbl.pdf
12/16/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021692s013s014lbl.pdf
02/20/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021692s005s007lbl.pdf
02/20/2008	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021692s005s007lbl.pdf
08/03/2006	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021692s002lbl.pdf
09/08/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021692lbl.pdf

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