Details for New Drug Application (NDA): 021192

See Plans and Pricing

« Back to Dashboard

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

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)

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:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 80MG BASE
Approval Date:	Oct 6, 2000	TE:	AB	RLD:	Yes
Patent:	Start Trial	Patent Expiration:	Oct 13, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021192

Subscribe to access the full database, or Start Trial
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.