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Details for New Drug Application (NDA): 022224

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NDA 022224 describes TRILIPIX, which is a drug marketed by Abbvie and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the TRILIPIX profile page.

The generic ingredient in TRILIPIX is choline fenofibrate. There are ninety-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.

Summary for NDA: 022224

Tradename:
TRILIPIX
Applicant:
Abbvie
Ingredient:
choline fenofibrate
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 022224

Suppliers and Packaging for NDA: 022224

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRILIPIX
choline fenofibrate
CAPSULE, DELAYED RELEASE;ORAL 022224 NDA AbbVie Inc. 0074-3161 0074-3161-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0074-3161-90)
TRILIPIX
choline fenofibrate
CAPSULE, DELAYED RELEASE;ORAL 022224 NDA AbbVie Inc. 0074-3162 0074-3162-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0074-3162-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Dec 15, 2008TE:ABRLD:No
Patent:7,259,186Patent Expiration:Jan 7, 2025Product Flag?Substance Flag?YDelist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Dec 15, 2008TE:ABRLD:Yes
Patent:7,259,186Patent Expiration:Jan 7, 2025Product Flag?Substance Flag?YDelist Request?


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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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