Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Accenture
Merck
Moodys
Medtronic
Farmers Insurance
Argus Health
Johnson and Johnson
US Department of Justice
Citi
Teva

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078061

« Back to Dashboard

NDA 078061 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-three suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 078061
Tradename:LINEZOLID
Applicant:Teva Pharms Usa
Ingredient:linezolid
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 078061
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 078061
Suppliers and Packaging for NDA: 078061
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid TABLET;ORAL 078061 ANDA Teva Pharmaceuticals USA, Inc. 0093-7490 N 0093-7490-34
LINEZOLID linezolid TABLET;ORAL 078061 ANDA Teva Pharmaceuticals USA, Inc. 0093-7490 N 0093-7490-65

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:May 18, 2015TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Daiichi Sankyo
QuintilesIMS
Citi
Fuji
US Department of Justice
Chubb
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot