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Last Updated: August 1, 2021

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Details for New Drug Application (NDA): 076635


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NDA 076635 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic Labs, Alembic Pharms Ltd, Amneal, Aurobindo Pharma Ltd, Austarpharma, Cipla, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Sun Pharm, Valeant Pharms North, Ani Pharms, Apotex, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, and Torrent, and is included in forty-one NDAs. It is available from forty-one 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-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 076635
Tradename:FENOFIBRATE
Applicant:Sun Pharm Inds Ltd
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076635
Medical Subject Heading (MeSH) Categories for 076635
Suppliers and Packaging for NDA: 076635
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 076635 ANDA NORTHSTAR RXLLC 16714-162 16714-162-01 90 TABLET, FILM COATED in 1 BOTTLE (16714-162-01)
FENOFIBRATE fenofibrate TABLET;ORAL 076635 ANDA NORTHSTAR RXLLC 16714-163 16714-163-01 90 TABLET, FILM COATED in 1 BOTTLE (16714-163-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Oct 31, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength107MG
Approval Date:Oct 31, 2005TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Oct 31, 2005TE:ABRLD:No

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