Last Updated: September 24, 2026

Details for New Drug Application (NDA): 219604

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NDA 219604 describes DALBAVANCIN HYDROCHLORIDE, which is a drug marketed by Be Pharms, Fresenius Kabi Usa, Kindos, Long Grove Pharms, and Teva Pharms Inc, and is included in five NDAs. It is available from six suppliers. Additional details are available on the DALBAVANCIN HYDROCHLORIDE profile page.

The generic ingredient in DALBAVANCIN HYDROCHLORIDE is dalbavancin hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.

Summary for 219604

Tradename:	DALBAVANCIN HYDROCHLORIDE
Applicant:	Be Pharms
Ingredient:	dalbavancin hydrochloride
Patents:	0

Pharmacology for NDA: 219604

Suppliers and Packaging for NDA: 219604

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DALBAVANCIN HYDROCHLORIDE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	219604	ANDA	Somerset Therapeutics, LLC	70069-830	70069-830-01	1 VIAL in 1 CARTON (70069-830-01) / 25 mL in 1 VIAL
DALBAVANCIN HYDROCHLORIDE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	219604	ANDA	BE Pharmaceuticals Inc.	71839-144	71839-144-01	1 VIAL in 1 CARTON (71839-144-01) / 25 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jun 4, 2026	TE:	AP	RLD:	No

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