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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
QuintilesIMS
Fish and Richardson
Cantor Fitzgerald
Johnson and Johnson
Baxter
Covington
Express Scripts
Chubb

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204475

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NDA 204475 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 204475
Tradename:FENOFIBRATE
Applicant:Mylan
Ingredient:fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204475
Medical Subject Heading (MeSH) Categories for 204475
Suppliers and Packaging for NDA: 204475
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 204475 ANDA Mylan Pharmaceuticals Inc. 0378-4390 N 0378-4390-77
FENOFIBRATE fenofibrate TABLET;ORAL 204475 ANDA Mylan Pharmaceuticals Inc. 0378-4391 N 0378-4391-77

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jun 23, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:Jun 23, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Chubb
Merck
Boehringer Ingelheim
McKesson
Cantor Fitzgerald
Harvard Business School
Queensland Health
Julphar

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