Details for New Drug Application (NDA): 020261
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The generic ingredient in LESCOL 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 020261
Tradename: | LESCOL |
Applicant: | Novartis |
Ingredient: | fluvastatin sodium |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 31, 1993 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 31, 1993 | TE: | RLD: | Yes |
Expired US Patents for NDA 020261
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-001 | Dec 31, 1993 | 5,354,772*PED | ⤷ Subscribe |
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-002 | Dec 31, 1993 | 5,356,896*PED | ⤷ Subscribe |
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-002 | Dec 31, 1993 | 5,354,772*PED | ⤷ Subscribe |
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-001 | Dec 31, 1993 | 5,356,896*PED | ⤷ Subscribe |
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