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Serving leading biopharmaceutical companies globally:

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US Department of Justice
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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065401

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NDA 065401 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Akorn, Fresenius Kabi Usa, Lupin Ltd, Strides Pharma, Watson Labs, Aurobindo Pharma Ltd, Cft Pharms Llc, Emcure Pharms Ltd, Gland Pharma Ltd, Hospira, Hospira Inc, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Xellia Pharms Aps, and Samson Medcl, and is included in thirty-four NDAs. It is available from twenty-four 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 065401
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Mustafa Nevzat Ilac
Ingredient:vancomycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065401
Ingredient-typeGlycopeptides
Medical Subject Heading (MeSH) Categories for 065401
Suppliers and Packaging for NDA: 065401
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 065401 ANDA Mylan Institutional LLC 67457-222 E 67457-222-20
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 065401 ANDA Mylan Institutional LLC 67457-225 E 67457-225-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 30, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jun 30, 2008TE:APRLD:No

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Deloitte
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US Army
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Chubb
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