Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021692
Company: VALEANT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTRAM ER TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
ULTRAM ER TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
ULTRAM ER TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes 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
09/08/2005 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.cfm
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English