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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 213895

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NDA 213895 describes VANCOMYCIN, which is a drug marketed by Xellia Pharms Aps, 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, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare, and is included in fifty-four NDAs. There are six patents protecting this drug. Additional details are available on the VANCOMYCIN profile page.

The generic ingredient in VANCOMYCIN 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 213895

Tradename:	VANCOMYCIN
Applicant:	Xellia Pharms Aps
Ingredient:	vancomycin
Patents:	5

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS, ORAL			Strength	5GM/100ML (50MG/ML)
Approval Date:	Aug 26, 2021	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 6, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING BACTERIAL INFECTIONS
Patent:	⤷ Sign Up	Patent Expiration:	Nov 6, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING BACTERIAL INFECTIONS
Patent:	⤷ Sign Up	Patent Expiration:	Nov 6, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

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