Treats acute bacterial skin and skin structure infections (ABSSSI) caused by designated…. Sold as Dalvance. Every FDA application for this active ingredient: 1 branded and 5 generic.
As of Nov 15, 2026, FDA lists 6 applications for Dalbavancin Hydrochloride (sold as Dalvance), first approved May 23, 2014, with 2 new uses approved and 0 published complete response letters.
| Dalvance | Part B | $69.8M | +17% | 8,818 |
| Dalvance | Part D | $20.3M | +14% | 1,834 |
| Dalbavancin HCl | Part D | $478K | New | 71 |
| May 23, 2014 | DalvanceNDA 21883 · New molecular entity | Abbvie | 7 | Marketed |
| Oct 23, 2025 | Dalbavancin HydrochlorideANDA 219465 | Teva Pharms Inc | 0 | Marketed |
| Nov 10, 2025 | Dalbavancin HydrochlorideANDA 217591 | Fresenius Kabi USA | 0 | Marketed |
| Nov 26, 2025 | Dalbavancin HydrochlorideANDA 218929 | Kindos | 0 | Marketed |
| Feb 26, 2026 | Dalbavancin HydrochlorideANDA 218602 | Long Grove Pharms | 0 | Marketed |
| Jun 4, 2026 | Dalbavancin HydrochlorideANDA 219604 | Be Pharms | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Abbvie
Fresenius Kabi USA