Details for New Drug Application (NDA): 022118

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NDA 022118 describes FENOGLIDE, which is a drug marketed by Salix and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FENOGLIDE profile page.

The generic ingredient in FENOGLIDE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 022118

Tradename:	FENOGLIDE
Applicant:	Salix
Ingredient:	fenofibrate
Patents:	4

Medical Subject Heading (MeSH) Categories for 022118

Hypolipidemic Agents

Suppliers and Packaging for NDA: 022118

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOGLIDE	fenofibrate	TABLET;ORAL	022118	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1522	0115-1522-10	90 TABLET in 1 BOTTLE (0115-1522-10)
FENOGLIDE	fenofibrate	TABLET;ORAL	022118	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1523	0115-1523-10	90 TABLET in 1 BOTTLE (0115-1523-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Aug 10, 2007	TE:		RLD:	Yes
Patent:	7,658,944	Patent Expiration:	Dec 9, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,124,125	Patent Expiration:	Oct 1, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA
Patent:	8,481,078	Patent Expiration:	Oct 1, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES

Expired US Patents for NDA 022118

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	7,658,944	⤷ Subscribe
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	7,658,944	⤷ Subscribe
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	8,481,078	⤷ Subscribe
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	8,124,125	⤷ Subscribe
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	9,173,847	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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