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QuintilesIMS
McKesson
Johnson and Johnson
Colorcon
US Army
Queensland Health
Farmers Insurance
Mallinckrodt
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Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200904

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NDA 200904 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 200904
Tradename:LINEZOLID
Applicant:Sandoz Inc
Ingredient:linezolid
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 200904
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 200904
Suppliers and Packaging for NDA: 200904
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid SOLUTION;INTRAVENOUS 200904 ANDA Sandoz Inc 0781-3431 N 0781-3431-46
LINEZOLID linezolid SOLUTION;INTRAVENOUS 200904 ANDA Sandoz Inc 0781-3431 N 0781-3431-95

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/100ML (2MG/ML)
Approval Date:Jul 16, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength600MG/300ML (2MG/ML)
Approval Date:Jul 16, 2015TE:APRLD:No

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