Details for New Drug Application (NDA): 020261

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NDA 020261 describes LESCOL, which is a drug marketed by Novartis and Sandoz and is included in two NDAs. 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. Five suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.

Summary for 020261

Tradename:	LESCOL
Applicant:	Novartis
Ingredient:	fluvastatin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 31, 1993	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 31, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 020261

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993	5,354,772*PED	⤷ Get Started Free
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993	5,356,896*PED	⤷ Get Started Free
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993	5,354,772*PED	⤷ Get Started Free
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993	5,356,896*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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