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BUPRENORPHINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ASCENT PHARMS INC · Approved 2025-12-18

Drug application

FDA Application #

ANDA219401

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUPRENORPHINE HYDROCHLORIDE

Generic name

BUPRENORPHINE HCL

Active ingredients

BUPRENORPHINE HYDROCHLORIDE

Dosage form

TABLET

Route

SUBLINGUAL

Marketing status

Prescription

Sponsor

ASCENT PHARMS INC

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2025-12-18

Source

Authoritative

Drugs@FDA application overview

Machine

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