# SAPROPTERIN DIHYDROCHLORIDE
> **ANDA216432** · Abbreviated New Drug Application (Generic) · Sponsor: TP ANDA HOLDINGS · Approved 2025-09-03
## Drug
- **FDA Application Number:** ANDA216432
- **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:** TP ANDA HOLDINGS
- **Manufacturer:** TRUPHARMA, LLC
- **First approval:** 2025-09-03
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216432)
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