# KUVAN
> **NDA205065** · New Drug Application · Sponsor: BIOMARIN PHARM · Approved 2013-12-19
## Drug
- **FDA Application Number:** NDA205065
- **Application type:** New Drug Application
- **Brand name:** KUVAN
- **Generic name:** SAPROPTERIN DIHYDROCHLORIDE
- **Active ingredients:** SAPROPTERIN DIHYDROCHLORIDE
- **Dosage form:** POWDER
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** BIOMARIN PHARM
- **Manufacturer:** BioMarin Pharmaceutical Inc.
- **First approval:** 2013-12-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205065)
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