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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021192

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NDA 021192 describes LESCOL XL, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the LESCOL XL profile page.

The generic ingredient in LESCOL XL is fluvastatin sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
Summary for 021192
Tradename:LESCOL XL
Applicant:Novartis
Ingredient:fluvastatin sodium
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021192
Suppliers and Packaging for NDA: 021192
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192 NDA Novartis Pharmaceuticals Corporation 0078-0354 0078-0354-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-05)
LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192 NDA Novartis Pharmaceuticals Corporation 0078-0354 0078-0354-15 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-15)
Paragraph IV (Patent) Challenges for 021192
Tradename Dosage Ingredient NDA Submissiondate
LESCOL XL TABLET, EXTENDED RELEASE;ORAL fluvastatin sodium 021192 2007-03-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 80MG BASE
Approval Date:Oct 6, 2000TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Oct 13, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021192

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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