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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022118

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NDA 022118 describes FENOGLIDE, which is a drug marketed by Santarus Inc and is included in one NDA. It is available from four suppliers. 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-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 022118

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022118

Medical Subject Heading (MeSH) Categories for 022118

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 Impax Generics 0115-1522 0115-1522-10 90 TABLET in 1 BOTTLE (0115-1522-10)
FENOGLIDE fenofibrate TABLET;ORAL 022118 NDA AUTHORIZED GENERIC Impax Generics 0115-1523 0115-1523-10 90 TABLET in 1 BOTTLE (0115-1523-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 10, 2007TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Dec 9, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Oct 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA
Patent:► SubscribePatent Expiration:Oct 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES


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