Last Updated: June 17, 2026

Details for New Drug Application (NDA): 065401

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NDA 065401 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Lupin, Orient Pharma Co Ltd, Pai Holdings, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Eurofarma, Gland, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Plano Pharms, Sagent Pharms, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Samson Medcl, Steriscience, Zhejiang Novus Pharm, and Baxter Hlthcare, and is included in fifty-four NDAs. It is available from twenty-eight 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-four suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

Summary for 065401

Tradename:	VANCOMYCIN HYDROCHLORIDE
Applicant:	Eurofarma
Ingredient:	vancomycin hydrochloride
Patents:	0

Pharmacology for NDA: 065401

Medical Subject Heading (MeSH) Categories for 065401

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jun 30, 2008	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Jun 30, 2008	TE:	AP	RLD:	No

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