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Serving leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
McKesson
Moodys
Johnson and Johnson
Dow
AstraZeneca
Covington
Medtronic
Teva

Generated: January 24, 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, Aurobindo Pharma Ltd, Cipla Ltd, 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-two 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 31722-595-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-595-30)
FENOFIBRATE fenofibrate TABLET;ORAL 204598 ANDA Camber Pharmaceuticals, Inc. 31722-595 31722-595-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-595-90)

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 leading biopharmaceutical companies globally:

UBS
Mallinckrodt
Chubb
AstraZeneca
Julphar
Express Scripts
Accenture
Dow
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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