.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

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

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
Julphar
Fish and Richardson
Covington
McKesson
Cipla
US Army
Baxter
Chubb

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076635

« Back to Dashboard

NDA 076635 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mylan, Mylan Pharms Inc, Rhodes Pharms, Valeant Pharms North, Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Invagen Pharms, and is included in twenty-two NDAs. It is available from thirty-five suppliers. Additional details are available on the FENOFIBRATE profile page.

The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 076635

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076635

Medical Subject Heading (MeSH) Categories for 076635

Suppliers and Packaging for NDA: 076635

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 076635 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-001 43353-001-19 3060 TABLET, FILM COATED in 1 BOTTLE (43353-001-19)
FENOFIBRATE fenofibrate TABLET;ORAL 076635 ANDA Northwind Pharmaceuticals, LLC 51655-901 51655-901-52 30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-901-52)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Oct 31, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength107MG
Approval Date:Oct 31, 2005TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Oct 31, 2005TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Covington
Fish and Richardson
AstraZeneca
Colorcon
Dow
UBS
Cerilliant
Moodys
QuintilesIMS
Federal Trade Commission

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot