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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215324


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NDA 215324 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Abon Pharms Llc, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Plano Pharms, Sagent Pharms, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Steriscience, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare, and is included in fifty-four NDAs. It is available from twenty-five suppliers. Additional details are available on the VANCOMYCIN HYDROCHLORIDE profile page.

The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 215324
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Steriscience
Ingredient:vancomycin hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 215324
Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 750MG BASE/VIAL
Approval Date:Oct 2, 2025TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 1.25GM BASE/VIAL
Approval Date:Oct 2, 2025TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 1.5GM BASE/VIAL
Approval Date:Oct 2, 2025TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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