You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 11, 2025

Details for New Drug Application (NDA): 090856

✉ Email this page to a colleague

« Back to Dashboard

NDA 090856 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic, Amneal, Aurobindo Pharma, Bausch, Bostal, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Rising, Sun Pharm, Yichang Humanwell, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, Pharmobedient, Reyoung, and Torrent, and is included in forty-seven NDAs. It is available from forty-seven 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-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 090856

Tradename:	FENOFIBRATE
Applicant:	Lupin Ltd
Ingredient:	fenofibrate
Patents:	0

Pharmacology for NDA: 090856

Medical Subject Heading (MeSH) Categories for 090856

Hypolipidemic Agents

Suppliers and Packaging for NDA: 090856

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	090856	ANDA	Major Pharmaceuticals	0904-7480	0904-7480-04	30 BLISTER PACK in 1 CARTON (0904-7480-04) / 1 TABLET in 1 BLISTER PACK
FENOFIBRATE	fenofibrate	TABLET;ORAL	090856	ANDA	Major Pharmaceuticals	0904-7480	0904-7480-61	100 BLISTER PACK in 1 CARTON (0904-7480-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	48MG
Approval Date:	Dec 23, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	145MG
Approval Date:	Dec 23, 2011	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.