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FDA NDA · NDA214094

ORLADEYO

berotralstat hydrochloride

Sponsor: BIOCRYST

APPLICATION
NDA214094
TYPE
NDA
ORIGINAL APPROVAL
2020-12-03
LATEST ACTION
2025-12-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ORLADEYO · ReferencePrescription
BEROTRALSTAT DIHYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
ORLADEYO · ReferencePrescription
BEROTRALSTAT DIHYDROCHLORIDE EQ 110MG BASE · CAPSULE · ORAL

Approval history

2025-12-23Labeling · Supplement 5 · standard — Letter ↗AP
2024-10-21Labeling · Supplement 3 · standard — Letter ↗AP
2023-11-21Labeling · Supplement 2 · standard — Label ↗AP
2020-12-03Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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