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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 211080


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NDA 211080 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic, Amneal, Aurobindo Pharma, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, 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, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, Reyoung, Rising, Torrent, and Youngtech Pharms Inc, and is included in forty-five 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-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 211080
Tradename:FENOFIBRATE
Applicant:Prinston Inc
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211080
Medical Subject Heading (MeSH) Categories for 211080
Suppliers and Packaging for NDA: 211080
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 211080 ANDA Solco Healthcare US, LLC 43547-430 43547-430-09 90 TABLET in 1 BOTTLE (43547-430-09)
FENOFIBRATE fenofibrate TABLET;ORAL 211080 ANDA Solco Healthcare US, LLC 43547-430 43547-430-50 500 TABLET in 1 BOTTLE (43547-430-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength48MG
Approval Date:Aug 28, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength145MG
Approval Date:Aug 28, 2018TE:ABRLD:No

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