← FDA Drug Approvals (Drugs@FDA)
SAPROPTERIN DIHYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TP ANDA HOLDINGS · Approved 2025-09-03
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown