Details for New Drug Application (NDA): 021192
✉ Email this page to a colleague
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 |
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 | 0078-0354-15 | 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: | 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
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 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | 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 |
Complete Access Available with Subscription