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Details for New Drug Application (NDA): 021656

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NDA 021656 describes TRICOR, which is a drug marketed by Abbott and Abbvie and is included in three NDAs. It is available from eleven suppliers. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TRICOR profile page.

The generic ingredient in TRICOR 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: 021656

Tradename:
TRICOR
Applicant:
Abbvie
Ingredient:
fenofibrate
Patents:7
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021656

Suppliers and Packaging for NDA: 021656

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRICOR
fenofibrate
TABLET;ORAL 021656 NDA AbbVie Inc. 0074-3173 0074-3173-90 90 TABLET in 1 BOTTLE (0074-3173-90)
TRICOR
fenofibrate
TABLET;ORAL 021656 NDA AbbVie Inc. 0074-3189 0074-3189-90 90 TABLET in 1 BOTTLE (0074-3189-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength48MG
Approval Date:Nov 5, 2004TE:ABRLD:No
Patent:6,277,405Patent Expiration:Jan 9, 2018Product Flag?Substance Flag?YDelist Request?
Patent:6,652,881Patent Expiration:Jan 9, 2018Product Flag?Substance Flag?YDelist Request?
Patent:7,037,529Patent Expiration:Jan 9, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021656

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-001Nov 5, 20045,145,684► subscribe
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-002Nov 5, 20045,145,684► subscribe
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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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