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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
Fuji
Baxter
Federal Trade Commission
UBS
Chubb
Accenture
Cipla

Generated: June 19, 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, 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-four 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-five 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 31722-595-31

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
Queensland Health
Chubb
Colorcon
Cerilliant
McKinsey
Teva
QuintilesIMS
Baxter

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