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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-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the fenofibrate profile page.

Summary for NDA: 022118

Tradename:
FENOGLIDE
Applicant:
Santarus Inc
Ingredient:
fenofibrate
Patents:4
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Global Pharmaceuticals, Division of Impax Laboratories Inc. 0115-1522 0115-1522-10 90 TABLET in 1 BOTTLE (0115-1522-10)
FENOGLIDE
fenofibrate
TABLET;ORAL 022118 NDA AUTHORIZED GENERIC Global Pharmaceuticals, Division of Impax Laboratories Inc. 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:No
Patent:7,658,944Patent Expiration:Dec 9, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:9,173,847Patent Expiration:Oct 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,124,125Patent 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


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