Orange Book product · Generic (ANDA)
VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE
At a glance
Mar 21, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 21, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
VANCOMYCIN HYDROCHLORIDE
Strength
EQ 1.25GM BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
ANDA 218140
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of VANCOMYCIN HYDROCHLORIDE
- 2018FIRVANQ KITBrand (NDA)
NDA 208910 · AZURITY
- 1986VANCOCIN HYDROCHLORIDEBrand (NDA)
NDA 050606 · ANI PHARMS
- 2023VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215338 · AMNEAL
- 2022VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 214913 · ALKEM LABS LTD
- 2022VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215195 · MEITHEAL
- 2022VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215197 · MEITHEAL
- 2022VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215196 · MEITHEAL
- 2022VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 216591 · ASPIRO
- 2022VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 213059 · KNACK
- 2021VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215821 · SLATE RUN PHARMA
- 2020VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 203300 · HIKMA
- 2019VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 212332 · SLATE RUN PHARMA
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.
