# SAPROPTERIN DIHYDROCHLORIDE
> **ANDA210027** · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2019-08-20
## Drug
- **FDA Application Number:** ANDA210027
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SAPROPTERIN DIHYDROCHLORIDE
- **Generic name:** SAPROPTERIN DIHYDROCHLORIDE
- **Active ingredients:** SAPROPTERIN DIHYDROCHLORIDE
- **Dosage form:** POWDER
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PH HEALTH
- **Manufacturer:** Par Health USA, LLC
- **First approval:** 2019-08-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210027)
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