Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021232
Company: SWEDISH ORPHAN
Company: SWEDISH ORPHAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORFADIN | NITISINONE | 2MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ORFADIN | NITISINONE | 5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ORFADIN | NITISINONE | 10MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ORFADIN | NITISINONE | 20MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/17/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021232s023,206356s006lbl.pdf | |
| 09/01/2017 | SUPPL-20 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021232s020lbl.pdf | |
| 02/28/2017 | SUPPL-19 | Manufacturing (CMC)-Expiration Date | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021232s019lbl.pdf | |
| 06/13/2016 | SUPPL-17 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021232s017lbl.pdf |
| 05/21/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021232s013lbl.pdf | |
| 02/13/2013 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021232s010lbl.pdf | |
| 01/25/2010 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021232s008lbl.pdf | |
| 01/18/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21232lbl.pdf |