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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Julphar
Colorcon
Dow
Queensland Health
Medtronic
Covington
US Army
Teva

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205442

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NDA 205442 describes LINEZOLID, which is a drug marketed by West-ward Pharms Int, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira Inc, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms, Sandoz Inc, Teva Pharms, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Gate Pharms, Glenmark Pharms, Hetero Labs Ltd V, Mylan Pharms Inc, Novel Labs Inc, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in twenty-one NDAs. It is available from twenty-five suppliers. Additional details are available on the LINEZOLID profile page.

The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 205442
Tradename:LINEZOLID
Applicant:Hospira Inc
Ingredient:linezolid
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 205442
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 205442
Suppliers and Packaging for NDA: 205442
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid SOLUTION;INTRAVENOUS 205442 ANDA Hospira, Inc. 0409-4882 N 0409-4882-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength600MG/300ML (2MG/ML)
Approval Date:Jul 7, 2015TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Dow
Baxter
QuintilesIMS
Queensland Health
McKesson
Merck
Chubb
Healthtrust

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