Details for New Drug Application (NDA): 213059

NDA 213059 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare, and is included in fifty-three NDAs. It is available from twenty-five suppliers. There are five patents protecting this drug. 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 suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

Summary for 213059

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

Medical Subject Heading (MeSH) Categories for 213059

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Feb 15, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 750MG BASE/VIAL
Approval Date:	Feb 15, 2022	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Feb 15, 2022	TE:		RLD:	No

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