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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Boehringer Ingelheim
Cipla
Fuji
Johnson and Johnson
Colorcon
AstraZeneca
Healthtrust
QuintilesIMS

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076433

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NDA 076433 describes FENOFIBRATE, which is a drug marketed by Cipla Ltd, Impax Labs, Valeant Pharms North, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Rhodes Pharms, Sun Pharm Inds Ltd, Mylan Pharms Inc, Hetero Labs Ltd Iii, Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Invagen Pharms, and is included in twenty-one NDAs. It is available from thirty-two 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 NDA: 076433

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 42858-454-45 90 TABLET, FILM COATED in 1 BOTTLE (42858-454-45)
FENOFIBRATE
fenofibrate
TABLET;ORAL 076433 ANDA Rhodes Pharmaceuticals L.P. 42858-660 42858-660-45 90 TABLET, FILM COATED in 1 BOTTLE (42858-660-45)

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
US Army
Healthtrust
Cipla
Express Scripts
Moodys
Fish and Richardson
McKesson
Cerilliant
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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