# ORFADIN
> **NDA021232** · New Drug Application · Sponsor: SWEDISH ORPHAN · Approved 2002-01-18
## Drug
- **FDA Application Number:** NDA021232
- **Application type:** New Drug Application
- **Brand name:** ORFADIN
- **Generic name:** NITISINONE
- **Active ingredients:** NITISINONE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SWEDISH ORPHAN
- **Manufacturer:** SWEDISH ORPHAN BIOVITRUM AB (PUBL)
- **First approval:** 2002-01-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021232)
---
*MORVS · CC0 1.0*