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 three 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. Five 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

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 80MG BASE
Approval Date:	Oct 6, 2000	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Oct 13, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021192

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

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