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Last Updated: March 19, 2024

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 two suppliers. 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. Six 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
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 0078-0354-15 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-15)
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 80MG BASE
Approval Date:Oct 6, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021192

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

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