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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Fuji
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US Department of Justice
Daiichi Sankyo
Federal Trade Commission
Baxter

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076433

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NDA 076433 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 076433
Tradename:FENOFIBRATE
Applicant:Rhodes Pharms
Ingredient:fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076433
Medical Subject Heading (MeSH) Categories for 076433
Suppliers and Packaging for NDA: 076433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 076433 ANDA Rhodes Pharmaceuticals L.P. 42858-454 N 42858-454-45
FENOFIBRATE fenofibrate TABLET;ORAL 076433 ANDA Rhodes Pharmaceuticals L.P. 42858-660 N 42858-660-45

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:May 13, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:May 13, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Dow
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