Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020931
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIKOSYN | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| TIKOSYN | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| TIKOSYN | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/08/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020931s017lbl.pdf | |
| 03/08/2016 | SUPPL-13 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf | |
| 03/08/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf | |
| 12/06/2013 | SUPPL-7 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020931s007lbl.pdf | |
| 12/06/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020931s007lbl.pdf | |
| 10/01/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20931lbl.pdf |