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FDA NDA · NDA219666

SEPHIENCE

sepiapterin

Sponsor: PTC THERAP

APPLICATION
NDA219666
TYPE
NDA
ORIGINAL APPROVAL
2025-07-28
LATEST ACTION
2025-07-28
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

SEPHIENCE · ReferencePrescription
SEPIAPTERIN 1GM/PACKET · POWDER · ORAL
SEPHIENCE · ReferencePrescription
SEPIAPTERIN 250MG/PACKET · POWDER · ORAL

Approval history

2025-07-28Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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