# NITISINONE
> **ANDA216201** · Abbreviated New Drug Application (Generic) · Sponsor: ETON · Approved 2023-05-25
## Drug
- **FDA Application Number:** ANDA216201
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** NITISINONE
- **Generic name:** NITISINONE
- **Active ingredients:** NITISINONE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ETON
- **Manufacturer:** Eton Pharmaceuticals, Inc.
- **First approval:** 2023-05-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216201)
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