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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204019


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NDA 204019 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Adaptis, 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-two NDAs. It is available from forty 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 204019
Tradename:FENOFIBRATE
Applicant:Lupin Ltd
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204019
Medical Subject Heading (MeSH) Categories for 204019
Suppliers and Packaging for NDA: 204019
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate TABLET;ORAL 204019 ANDA Major Pharmaceuticals 0904-6810 0904-6810-04 30 BLISTER PACK in 1 CARTON (0904-6810-04) > 1 TABLET in 1 BLISTER PACK
FENOFIBRATE fenofibrate TABLET;ORAL 204019 ANDA Major Pharmaceuticals 0904-7128 0904-7128-04 30 BLISTER PACK in 1 CARTON (0904-7128-04) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Aug 17, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Aug 17, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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