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BRIXADI

NDA · New Drug Application · Sponsor: BRAEBURN · Approved 2023-05-23

Drug application

FDA Application #

NDA210136

Application type

New Drug Application

Brand name

BRIXADI

Generic name

BUPRENORPHINE

Active ingredients

BUPRENORPHINE

Dosage form

SOLUTION, EXTENDED RELEASE

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

BRAEBURN

Manufacturer

Braeburn Inc.

First approval

2023-05-23

Source

Authoritative

Drugs@FDA application overview

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