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ZUBSOLV

NDA · New Drug Application · Sponsor: EDENBRIDGE PHARMS · Approved 2013-07-03

Drug application

FDA Application #

NDA204242

Application type

New Drug Application

Brand name

ZUBSOLV

Generic name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Active ingredients

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Dosage form

TABLET

Route

SUBLINGUAL

Marketing status

Prescription

Sponsor

EDENBRIDGE PHARMS

Manufacturer

Orexo US, Inc.

First approval

2013-07-03

Source

Authoritative

Drugs@FDA application overview

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