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Details for New Drug Application (NDA): 021203

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NDA 021203 describes TRICOR, which is a drug marketed by Abbott and Abbvie and is included in three NDAs. It is available from fourteen 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-nine 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: 021203

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 4, 2001TE:RLD:Yes
Patent:6,074,670Patent Expiration:Jan 9, 2018Product Flag?Substance Flag?Delist Request?
Patent:6,277,405Patent Expiration:Jan 9, 2018Product Flag?Substance Flag?Delist Request?
Patent:6,589,552Patent Expiration:Jan 9, 2018Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021203

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbott
TRICOR
fenofibrate
TABLET;ORAL021203-001Sep 4, 20014,895,726► Subscribe
Abbott
TRICOR
fenofibrate
TABLET;ORAL021203-003Sep 4, 20014,895,726► 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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