# ONGENTYS
> **NDA212489** · New Drug Application · Sponsor: AMNEAL · Approved 2020-04-24
## Drug
- **FDA Application Number:** NDA212489
- **Application type:** New Drug Application
- **Brand name:** ONGENTYS
- **Generic name:** OPICAPONE
- **Active ingredients:** OPICAPONE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL
- **Manufacturer:** Amneal Pharmaceuticals LLC
- **First approval:** 2020-04-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212489)
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