# NITISINONE
> **ANDA212390** · Abbreviated New Drug Application (Generic) · Sponsor: MEDUNIK · Approved 2022-05-26
## Drug
- **FDA Application Number:** ANDA212390
- **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:** MEDUNIK
- **Manufacturer:** Analog Pharma
- **First approval:** 2022-05-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212390)
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