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FDA NDA · NDA219776

ORLADEYO

berotralstat hydrochloride

Sponsor: BIOCRYST

APPLICATION
NDA219776
TYPE
NDA
ORIGINAL APPROVAL
2025-12-11
LATEST ACTION
2025-12-11
ROUTE
ORAL
DOSAGE FORM
PELLETS
MARKETING STATUS
Prescription

Products

ORLADEYO · ReferencePrescription
BEROTRALSTAT DIHYDROCHLORIDE EQ 132MG BASE/PACKET · PELLETS · ORAL
ORLADEYO · ReferencePrescription
BEROTRALSTAT DIHYDROCHLORIDE EQ 96MG BASE/PACKET · PELLETS · ORAL
ORLADEYO · ReferencePrescription
BEROTRALSTAT DIHYDROCHLORIDE EQ 108MG BASE/PACKET · PELLETS · ORAL
ORLADEYO · ReferencePrescription
BEROTRALSTAT DIHYDROCHLORIDE EQ 72MG BASE/PACKET · PELLETS · ORAL

Approval history

2025-12-11Type 3 - New Dosage Form · Original · priority — Letter ↗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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