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Last Updated: August 10, 2020

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Details for New Drug Application (NDA): 210606

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NDA 210606 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Llc, Appco, Aurobindo Pharma Ltd, Austarpharma, Cipla, Graviti Pharms, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Orit Labs Llc, Prinston Inc, Rhodes Pharms, Sun Pharm, Valeant Pharms North, Ani Pharms Inc, Apotex, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, and Torrent, and is included in thirty-nine 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-five suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 210606
Tradename:FENOFIBRATE
Applicant:Graviti Pharms
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210606
Medical Subject Heading (MeSH) Categories for 210606
Suppliers and Packaging for NDA: 210606
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 210606 ANDA Laurus Labs Limited 42385-935 42385-935-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05)
FENOFIBRATE fenofibrate TABLET;ORAL 210606 ANDA Laurus Labs Limited 42385-935 42385-935-11 1000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Aug 17, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Aug 17, 2018TE:ABRLD:No

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