Drug application

DALBAVANCIN HYDROCHLORIDE (DALBAVANCIN HYDROCHLORIDE)

Drugs@FDA ANDA 218929 · KINDOS

Key facts

Drug name DALBAVANCIN HYDROCHLORIDE
Active ingredients DALBAVANCIN HYDROCHLORIDE
Application type ANDA
Application number 218929
Company KINDOS
Dosage forms POWDER, INTRAVENOUS
Strength EQ 500MG BASE/VIAL
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Nov 26, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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