# ZELVYSIA
> **ANDA218645** · Abbreviated New Drug Application (Generic) · Sponsor: AUCTA · Approved 2025-04-29
## Drug
- **FDA Application Number:** ANDA218645
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ZELVYSIA
- **Generic name:** SAPROPTERIN DIHYDROCHLORIDE
- **Active ingredients:** SAPROPTERIN DIHYDROCHLORIDE
- **Dosage form:** POWDER
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AUCTA
- **Manufacturer:** Aucta Pharmaceuticals, Inc.
- **First approval:** 2025-04-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218645)
---
*AI Analytics · CC0 1.0*