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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS ELIZABETH · Approved 2013-02-22

Drug application

FDA Application #

ANDA091422

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Generic name

BUPRENORPHINE AND NALOXONE

Active ingredients

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Dosage form

TABLET

Route

SUBLINGUAL

Marketing status

Prescription

Sponsor

ACTAVIS ELIZABETH

Manufacturer

Actavis Pharma, Inc.

First approval

2013-02-22

Source

Authoritative

Drugs@FDA application overview

Machine

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