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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Merck
UBS
Healthtrust
Medtronic
Federal Trade Commission
Covington
Chubb

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205118

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NDA 205118 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 205118
Tradename:FENOFIBRATE
Applicant:Aurobindo Pharma Ltd
Ingredient:fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205118
Medical Subject Heading (MeSH) Categories for 205118
Suppliers and Packaging for NDA: 205118
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 205118 ANDA NorthStar Rx LLC 16714-737 N 16714-737-01
FENOFIBRATE fenofibrate TABLET;ORAL 205118 ANDA NorthStar Rx LLC 16714-738 N 16714-738-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength48MG
Approval Date:May 5, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength145MG
Approval Date:May 5, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
US Army
Daiichi Sankyo
Argus Health
Queensland Health
Express Scripts
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