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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALVOGEN · Approved 2019-01-24

Drug application

FDA Application #

ANDA205954

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

FILM

Route

BUCCAL, SUBLINGUAL

Marketing status

Prescription

Sponsor

ALVOGEN

Manufacturer

Alvogen Inc.

First approval

2019-01-24

Source

Authoritative

Drugs@FDA application overview

Machine

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