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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021745
Company: PURDUE PHARMA

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RYZOLT TRAMADOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
RYZOLT TRAMADOL HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
RYZOLT TRAMADOL HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/2008 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021745s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021745s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021745_ryzolt_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021745s000_SumR.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/30/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021745s000lbl.pdf
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