
Summary for Tradename: LESCOL
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| Applicant | Tradename | Generic Name | NDA | Approval Date | Type | RLD | Patent Number | Product | Substance | Delist Req. | Patent Expiration | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | LESCOL | fluvastatin sodium | 020261 | Dec 31, 1993 | RX | No | Oct 10, 2009 | |||||
| Novartis | LESCOL | fluvastatin sodium | 020261 | Dec 31, 1993 | RX | No | 5,354,772*PED | Y | Apr 11, 2012 | |||
| Novartis | LESCOL | fluvastatin sodium | 020261 | Dec 31, 1993 | RX | No | 5,356,896*PED | Y | Jun 12, 2012 |
| Drugname | Dosage | Strength | RLD | Submissiondate |
| fluvastatin | Capsules | 20 mg and 40 mg | Lescol | 6/4/2008 |
| fluvastatin sodium | Extended-release Tablets | 80 mg | Lescol XL | 3/15/2007 |
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