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Details for New Drug Application (NDA): 021192
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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.
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
| 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 |
| 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 |
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