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AstraZeneca
Citi
Cantor Fitzgerald
Federal Trade Commission
Teva
QuintilesIMS
Covington
Chubb
US Army

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076509

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NDA 076509 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Amneal Pharms Llc, Aurobindo Pharma Ltd, Cipla Ltd, Cnty Line Pharms, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mylan, Mylan Pharms Inc, Rhodes Pharms, Valeant Pharms North, Amerigen Pharms Ltd, Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Invagen Pharms, and is included in twenty-seven NDAs. It is available from thirty-three 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 076509
Tradename:FENOFIBRATE
Applicant:Impax Labs
Ingredient:fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076509
Medical Subject Heading (MeSH) Categories for 076509
Suppliers and Packaging for NDA: 076509
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 076509 ANDA Impax Generics 0115-5511 N 0115-5511-01
FENOFIBRATE fenofibrate TABLET;ORAL 076509 ANDA Impax Generics 0115-5511 N 0115-5511-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Mar 26, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Mar 26, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Express Scripts
Argus Health
Citi
Colorcon
McKesson
Daiichi Sankyo
Chinese Patent Office
Dow

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