Last Updated: September 24, 2026

Details for New Drug Application (NDA): 217591

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NDA 217591 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 217591

Tradename:	DALBAVANCIN HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	dalbavancin hydrochloride
Patents:	0

Pharmacology for NDA: 217591

Suppliers and Packaging for NDA: 217591

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DALBAVANCIN HYDROCHLORIDE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	217591	ANDA	Fresenius Kabi USA, LLC	65219-120	65219-120-12	1 VIAL in 1 PACKAGE (65219-120-12) / 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:	Nov 10, 2025	TE:	AP	RLD:	No

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