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Details for New Drug Application (NDA): 076520

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NDA 076520 describes FENOFIBRATE, which is a drug marketed by Impax Labs, Valeant Pharms North, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Teva, Sun Pharm Inds Ltd, Mylan Pharms Inc, Hetero Labs Ltd Iii, Apotex Inc, and Dr Reddys Labs Sa, and is included in eighteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the FENOFIBRATE profile page.

The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-one drug master file entries for this compound. Forty-five suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the fenofibrate profile page.

Summary for NDA: 076520

Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 076520

Suppliers and Packaging for NDA: 076520

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 076520 ANDA Mylan Pharmaceuticals Inc. 0378-7100 0378-7100-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7100-77)
TABLET;ORAL 076520 ANDA Mylan Pharmaceuticals Inc. 0378-7101 0378-7101-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7101-77)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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