Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021016
Company: UPJOHN
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RELPAX | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| RELPAX | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21016s029lbl.pdf | |
| 10/03/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf | |
| 10/03/2013 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf | |
| 10/03/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf | |
| 10/03/2013 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf | |
| 04/13/2011 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021016s018lbl.pdf | |
| 07/21/2010 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf | |
| 07/21/2010 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf | |
| 12/26/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21016_relpax_lbl.pdf |