Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021693
Company: SHIONOGI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYBIX ODT TRAMADOL HYDROCHLORIDE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No 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
05/05/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021693lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021693ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021693s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/25/2010 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021693s004ltr.pdf
08/13/2010 SUPPL-2 Labeling-Proprietary Name Change Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021693s002ltr.pdf
07/12/2006 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021693s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/13/2010 SUPPL-2 Labeling-Proprietary Name Change Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s002lbl.pdf
06/25/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s004lbl.pdf
05/05/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021693lbl.pdf

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