Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021693
Company: SHIONOGI INC
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 |
| 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 |