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

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cipla
AstraZeneca
US Army
Deloitte
Farmers Insurance
Medtronic
Argus Health
Harvard Business School

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078845

« Back to Dashboard

NDA 078845 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 078845
Tradename:LINEZOLID
Applicant:Mylan Pharms Inc
Ingredient:linezolid
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 078845
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 078845
Suppliers and Packaging for NDA: 078845
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid TABLET;ORAL 078845 ANDA Mylan Pharmaceuticals Inc. 0378-7077 N 0378-7077-94
LINEZOLID linezolid TABLET;ORAL 078845 ANDA Mylan Institutional Inc. 42292-008 N 42292-008-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Dec 21, 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:

Teva
Cerilliant
QuintilesIMS
Cipla
Baxter
Merck
Julphar
US Department of Justice
Harvard Business School

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.