Quick answers
- What is Dalbavancin used for?
- The FDA-approved label (Dalvance, Allergan, Inc., January 13, 2025) says: “DALVANCE is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dalbavancin have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dalbavancin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dalbavancin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dalbavancin?
- 7 companies list prescription products of Dalbavancin in the FDA NDC Directory, including Meitheal Pharmaceuticals Inc., Long Grove Pharmaceuticals, LLC and Allergan, Inc..
What Dalbavancin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DALVANCE is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. …
— FDA label: Dalvance, Allergan, Inc., effective January 13, 2025. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Dalvance |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Meitheal Pharmaceuticals Inc.1 product
- Long Grove Pharmaceuticals, LLC1 product
- Allergan, Inc.1 product
- Fresenius Kabi USA, LLC1 product
- Somerset Therapeutics, LLC1 product
- BE Pharmaceuticals Inc.1 product
- Teva Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021883 DALVANCE | Abbvie | May 23, 2014 | 7, latest January 13, 2025 2025: Labeling · 2021: Efficacy · 2018: Labeling |
Generic approvals (5)
- ANDA219465Teva Pharms Inc · October 23, 2025
- ANDA217591Fresenius Kabi USA · November 10, 2025
- ANDA218929Kindos · November 26, 2025
- ANDA218602Long Grove Pharms · February 26, 2026
- ANDA219604Be Pharms · June 4, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1539243, 1539248 |
|---|---|
| SPL set ID of the quoted label | 4b4674d8-4d1e-4728-8465-d42ada33fa5c |
| FDA labels (SPL) | 7 |
| FDA applications | NDA021883, 5 ANDA |
| Active ingredients (FDA) | DALBAVANCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dalvance, Allergan, Inc., effective January 13, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →