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Chinese Patent Office
Fuji
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Chubb
Cipla

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204019

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NDA 204019 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-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 204019
Tradename:FENOFIBRATE
Applicant:Lupin Ltd
Ingredient:fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204019
Medical Subject Heading (MeSH) Categories for 204019
Suppliers and Packaging for NDA: 204019
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 204019 ANDA Proficient Rx LP 63187-681 N 63187-681-30
FENOFIBRATE fenofibrate TABLET;ORAL 204019 ANDA Proficient Rx LP 63187-681 N 63187-681-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Aug 17, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Aug 17, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
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Fish and Richardson
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