# ORFADIN
> **NDA206356** · New Drug Application · Sponsor: SWEDISH ORPHAN · Approved 2016-04-22
## Drug
- **FDA Application Number:** NDA206356
- **Application type:** New Drug Application
- **Brand name:** ORFADIN
- **Generic name:** NITISINONE
- **Active ingredients:** NITISINONE
- **Dosage form:** SUSPENSION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SWEDISH ORPHAN
- **Manufacturer:** Swedish Orphan Biovitrum AB (publ)
- **First approval:** 2016-04-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206356)
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