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Chubb
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Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020261

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NDA 020261 describes LESCOL, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the LESCOL profile page.

The generic ingredient in LESCOL is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.

Summary for 020261

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020261

Suppliers and Packaging for NDA: 020261

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LESCOL
fluvastatin sodium
CAPSULE;ORAL 020261 NDA Physicians Total Care, Inc. 54868-3329 54868-3329-0 30 CAPSULE in 1 BOTTLE, PLASTIC (54868-3329-0)
LESCOL
fluvastatin sodium
CAPSULE;ORAL 020261 NDA Physicians Total Care, Inc. 54868-4224 54868-4224-0 30 CAPSULE in 1 BOTTLE, PLASTIC (54868-4224-0)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Dec 31, 1993TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Dec 31, 1993TE:RLD:Yes

Expired Orange Book Patents for NDA: 020261

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-001Dec 31, 1993► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-002Dec 31, 1993► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-002Dec 31, 1993► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-001Dec 31, 1993► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Chinese Patent Office
UBS
Daiichi Sankyo
Accenture
Medtronic
US Department of Justice
Mallinckrodt
Julphar

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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