Drug application
DALBAVANCIN HYDROCHLORIDE (DALBAVANCIN HYDROCHLORIDE)
Drugs@FDA ANDA 217591 · FRESENIUS KABI USA
Key facts
| Drug name | DALBAVANCIN HYDROCHLORIDE |
|---|---|
| Active ingredients | DALBAVANCIN HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 217591 |
| Company | FRESENIUS KABI USA |
| Dosage forms | POWDER, INTRAVENOUS |
| Strength | EQ 500MG BASE/VIAL |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Nov 10, 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.