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Details for New Drug Application (NDA): 021350

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NDA 021350 describes TRIGLIDE, which is a drug marketed by Skyepharma Ag and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TRIGLIDE profile page.

The generic ingredient in TRIGLIDE 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: 021350

Tradename:
TRIGLIDE
Applicant:
Skyepharma Ag
Ingredient:
fenofibrate
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021350

Suppliers and Packaging for NDA: 021350

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIGLIDE
fenofibrate
TABLET;ORAL 021350 NDA Shionogi Inc. 59630-485 59630-485-30 1 BOTTLE in 1 CARTON (59630-485-30) > 30 TABLET in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:May 7, 2005TE:RLD:No
Patent:6,696,084Patent Expiration:Sep 11, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT CAN PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE WHICH IS AT LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:May 7, 2005TE:BXRLD:Yes
Patent:6,696,084Patent Expiration:Sep 11, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT CAN PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE WHICH IS AT LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM


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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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