# SAPROPTERIN DIHYDROCHLORIDE
> **ANDA218797** · Abbreviated New Drug Application (Generic) · Sponsor: ZENARA · Approved 2025-06-11
## Drug
- **FDA Application Number:** ANDA218797
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SAPROPTERIN DIHYDROCHLORIDE
- **Generic name:** SAPROPTERIN DIHYDROCHLORIDE
- **Active ingredients:** SAPROPTERIN DIHYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ZENARA
- **Manufacturer:** Hikma Pharmaceuticals USA Inc.
- **First approval:** 2025-06-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218797)
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