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DALBAVANCIN HYDROCHLORIDE

ANDA

DALBAVANCIN HYDROCHLORIDE | A219604 | BE PHARMACEUTICALS AG

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DALVANCE(TE code: AP)

API Supply Chain4 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDDALBAVANCIN HYDROCHLORIDE

DMF 354282021

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDDALBAVANCIN HYDROCHLORIDE (DB)

DMF 371862022

XELLIA PHARMACEUTICALS APSDALBAVANCIN HYDROCHLORIDE

DMF 393782024

CHENGDU YACHT BIOTECHNOLOGY CO LTDDALBAVANCIN HYDROCHLORIDE

DMF 408272024

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDInactiveDALBAVANCIN HYDROCHLORIDE

DMF 358742021

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — EQ 500MG BASE/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 4, 2026

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

BE Pharma's dalbavancin hydrochloride (NDA 219604) received FDA approval as a new antibacterial product.

New: New record