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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ASCENT PHARMS INC · Approved 2025-12-15

Drug application

FDA Application #

ANDA219727

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

ASCENT PHARMS INC

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2025-12-15

Source

Authoritative

Drugs@FDA application overview

Machine

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