Orange Book product · Generic (ANDA)
VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE
At a glance
Nov 18, 2021
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 18, 2021
4 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
VANCOMYCIN HYDROCHLORIDE
Strength
EQ 5GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 215821
Product number
001
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)
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NDA 050606 · ANI PHARMS
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ANDA 215338 · AMNEAL
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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
- 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.
