← FDA Drug Approvals (Drugs@FDA)

DALBAVANCIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BE PHARMS · Approved 2026-06-04

Drug application

FDA Application #

ANDA219604

Application type

Abbreviated New Drug Application (Generic)

Brand name

DALBAVANCIN HYDROCHLORIDE

Generic name

DALBAVANCIN

Active ingredients

DALBAVANCIN HYDROCHLORIDE

Dosage form

POWDER

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

BE PHARMS

Manufacturer

Somerset Therapeutics, LLC

First approval

2026-06-04

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown