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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Cerilliant
Argus Health
Federal Trade Commission
QuintilesIMS
US Army
Harvard Business School
Fish and Richardson

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204598

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NDA 204598 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, Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Invagen Pharms, and is included in twenty-six NDAs. It is available from thirty-one 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-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 204598
Tradename:FENOFIBRATE
Applicant:Hetero Labs Ltd Iii
Ingredient:fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204598
Medical Subject Heading (MeSH) Categories for 204598
Suppliers and Packaging for NDA: 204598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 204598 ANDA Camber Pharmaceuticals, Inc. 31722-595 N 31722-595-30
FENOFIBRATE fenofibrate TABLET;ORAL 204598 ANDA Camber Pharmaceuticals, Inc. 31722-595 N 31722-595-32

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength48MG
Approval Date:Jul 12, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength145MG
Approval Date:Jul 12, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Moodys
Citi
US Department of Justice
Colorcon
Medtronic
Julphar
Deloitte
Accenture

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