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Serving leading biopharmaceutical companies globally:

Citi
Merck
Cipla
Daiichi Sankyo
US Department of Justice
Argus Health
Express Scripts
Healthtrust
Fish and Richardson
Cerilliant

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062911

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NDA 062911 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 062911
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Hospira
Ingredient:vancomycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062911
Ingredient-typeGlycopeptides
Medical Subject Heading (MeSH) Categories for 062911
Suppliers and Packaging for NDA: 062911
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062911 ANDA Hospira, Inc. 0409-4332 0409-4332-01 10 VIAL in 1 TRAY (0409-4332-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062911 ANDA General Injectables & Vaccines, Inc 52584-332 52584-332-01 1 VIAL, SINGLE-DOSE in 1 BAG (52584-332-01) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Aug 4, 1988TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Julphar
Cantor Fitzgerald
UBS
Daiichi Sankyo
Medtronic
Accenture
Queensland Health
McKesson

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