You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076509

✉ Email this page to a colleague

« Back to Dashboard

NDA 076509 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, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Rising, Sun Pharm, Valeant Pharms North, Yichang Humanwell, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, and Torrent, and is included in forty-six NDAs. It is available from forty-four 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 076509

Tradename:	FENOFIBRATE
Applicant:	Impax Labs
Ingredient:	fenofibrate
Patents:	0

Pharmacology for NDA: 076509

Medical Subject Heading (MeSH) Categories for 076509

Hypolipidemic Agents

Suppliers and Packaging for NDA: 076509

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	076509	ANDA	Amneal Pharmaceuticals of New York LLC	0115-5511	0115-5511-01	100 TABLET in 1 BOTTLE (0115-5511-01)
FENOFIBRATE	fenofibrate	TABLET;ORAL	076509	ANDA	Amneal Pharmaceuticals of New York LLC	0115-5511	0115-5511-02	500 TABLET in 1 BOTTLE (0115-5511-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	54MG
Approval Date:	Mar 26, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	Mar 26, 2008	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. 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.