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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Dow
Mallinckrodt
Teva
Baxter
Fish and Richardson
Cerilliant
Chubb
Argus Health

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062663

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NDA 062663 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 062663
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:vancomycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062663
Ingredient-typeGlycopeptides
Medical Subject Heading (MeSH) Categories for 062663
Suppliers and Packaging for NDA: 062663
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062663 ANDA Fresenius Kabi USA, LLC 63323-203 N 63323-203-26
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062663 ANDA Fresenius Kabi USA, LLC 63323-203 N 63323-203-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Mar 17, 1987TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jul 31, 1987TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5GM BASE/VIAL
Approval Date:Jun 3, 1988TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Teva
Chinese Patent Office
QuintilesIMS
Deloitte
Argus Health
Merck
Boehringer Ingelheim
Johnson and Johnson

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