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Last Updated: February 25, 2021

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Details for New Drug Application (NDA): 091377

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NDA 091377 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Akorn, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Strides Pharma, Watson Labs, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Gland Pharma Ltd, Hainan Poly Pharm, Hikma, Hikma Pharms, Hospira, Hospira Inc, Mylan Labs Ltd, Pharm Assoc, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Xellia Pharms Aps, and Samson Medcl, and is included in forty-one NDAs. It is available from twenty suppliers. There are three 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. Twenty-five suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 091377
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Xellia Pharms Aps
Ingredient:vancomycin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091377

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Sep 9, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Sep 9, 2015TE:RLD:No

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