Details for New Drug Application (NDA): 021192

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NDA 021192 describes LESCOL XL, which is a drug marketed by Sandoz and is included in one NDA. It is available from one supplier. 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:	Sandoz
Ingredient:	fluvastatin sodium
Patents:	0

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 AUTHORIZED GENERIC	Sandoz Inc	0781-8017	0781-8017-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01)
LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-8017	0781-8017-31	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-31)

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

Expired US Patents for NDA 021192

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	⤷ Get Started Free	⤷ Get Started Free
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	⤷ Get Started Free	⤷ Get Started Free
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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