Orange Book product · Brand (NDA)
VANCOCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE
At a glance
Apr 15, 1986
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 15, 1986
40 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
VANCOMYCIN HYDROCHLORIDE
Strength
EQ 250MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 050606
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2018FIRVANQ KITBrand (NDA)
NDA 208910 · AZURITY
- 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
- 2019VANCOMYCIN HYDROCHLORIDEGeneric (ANDA)
ANDA 210729 · ORIENT PHARMA CO LTD
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.

