Last Updated: June 17, 2026

Details for New Drug Application (NDA): 090439

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NDA 090439 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 090439

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

Medical Subject Heading (MeSH) Categories for 090439

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 125MG BASE
Approval Date:	Jan 28, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Jan 28, 2015	TE:	AB	RLD:	No

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