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SUBUTEX

NDA · New Drug Application · Sponsor: INDIVIOR · Approved 2002-10-08

Drug application

FDA Application #

NDA020732

Application type

New Drug Application

Brand name

SUBUTEX

Generic name

Buprenorphine Hydrochloride

Active ingredients

BUPRENORPHINE HYDROCHLORIDE

Dosage form

TABLET

Route

SUBLINGUAL

Marketing status

Discontinued

Sponsor

INDIVIOR

First approval

2002-10-08

Source

Authoritative

Drugs@FDA application overview

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