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Fish and Richardson
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Generated: August 21, 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-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for NDA: 022118

Tradename:
1
Applicant:
1
Ingredient:
1
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 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?
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


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Serving 500+ biopharmaceutical companies globally:

Medtronic
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US Army

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 verifification 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.

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