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Queensland Health
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Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076520

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NDA 076520 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-five 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-seven suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 076520
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076520
Medical Subject Heading (MeSH) Categories for 076520
Suppliers and Packaging for NDA: 076520
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 076520 ANDA Mylan Pharmaceuticals Inc. 0378-7100 N 0378-7100-77
FENOFIBRATE fenofibrate TABLET;ORAL 076520 ANDA Mylan Pharmaceuticals Inc. 0378-7101 N 0378-7101-77

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Oct 25, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength107MG
Approval Date:Dec 29, 2005TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Oct 25, 2007TE:ABRLD:No

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