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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Merck
Boehringer Ingelheim
US Department of Justice
QuintilesIMS
US Army
Deloitte
Johnson and Johnson
Queensland Health

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090250

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NDA 090250 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 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-four suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 090250
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Sandoz
Ingredient:vancomycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090250
Ingredient-typeGlycopeptides
Medical Subject Heading (MeSH) Categories for 090250
Suppliers and Packaging for NDA: 090250
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 090250 ANDA Sandoz Inc 0781-3187 N 0781-3187-95
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 090250 ANDA Sandoz Inc 0781-3188 N 0781-3188-95

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Apr 27, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Apr 27, 2010TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Teva
McKesson
US Army
Express Scripts
Baxter
Daiichi Sankyo
Healthtrust

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