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ORLADEYO

NDA · New Drug Application · Sponsor: BIOCRYST · Approved 2020-12-03

Drug application

FDA Application #

NDA214094

Application type

New Drug Application

Brand name

ORLADEYO

Generic name

BEROTRALSTAT HYDROCHLORIDE

Active ingredients

BEROTRALSTAT DIHYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

BIOCRYST

Manufacturer

BioCryst Pharmaceuticals, Inc.

First approval

2020-12-03

Source

Authoritative

Drugs@FDA application overview

Machine

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