← FDA Drug Approvals (Drugs@FDA)
SEPHIENCE
NDA · New Drug Application · Sponsor: PTC THERAP · Approved 2025-07-28
Drug application
- FDA Application #
NDA219666- Application type
- New Drug Application
- Brand name
- SEPHIENCE
- Generic name
- SEPIAPTERIN
- Active ingredients
- SEPIAPTERIN
- Dosage form
- POWDER
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PTC THERAP
- Manufacturer
- allphamed Pharbil Arzneimittel GmbH
- First approval
- 2025-07-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown