Orange Book product · Generic (ANDA)
DALBAVANCIN HYDROCHLORIDE
DALBAVANCIN HYDROCHLORIDE
At a glance
Nov 26, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 26, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
DALBAVANCIN HYDROCHLORIDE
Strength
EQ 500MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
ANDA 218929
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DALBAVANCIN HYDROCHLORIDE
- 2014DALVANCEBrand (NDA)
NDA 021883 · ABBVIE
- 2026DALBAVANCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 219604 · BE PHARMS
- 2026DALBAVANCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 218602 · LONG GROVE PHARMS
- 2025DALBAVANCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 217591 · FRESENIUS KABI USA
- 2025DALBAVANCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 219465 · TEVA PHARMS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
