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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Teva
Baxter
Accenture
Colorcon
UBS
Medtronic
Fish and Richardson
Covington

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207526

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NDA 207526 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 207526
Tradename:LINEZOLID
Applicant:Novel Labs Inc
Ingredient:linezolid
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 207526
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 207526
Suppliers and Packaging for NDA: 207526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid TABLET;ORAL 207526 ANDA Novel Laboratories, Inc. 40032-022 N 40032-022-02
LINEZOLID linezolid TABLET;ORAL 207526 ANDA Novel Laboratories, Inc. 40032-022 N 40032-022-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Aug 22, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Johnson and Johnson
Teva
US Army
US Department of Justice
McKesson
AstraZeneca
Queensland Health

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