Fluvastatin - Generic Drug Details
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Generic filers with tentative approvals for FLUVASTATIN
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for fluvastatin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Beijing | FLUVASTATIN SODIUM | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 209397-001 | Apr 26, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Pharms Inc | FLUVASTATIN SODIUM | fluvastatin sodium | CAPSULE;ORAL | 090595-002 | Apr 11, 2012 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms | FLUVASTATIN SODIUM | fluvastatin sodium | CAPSULE;ORAL | 078407-002 | Jun 12, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | FLUVASTATIN SODIUM | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 079011-001 | Jan 27, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Pharms Inc | FLUVASTATIN SODIUM | fluvastatin sodium | CAPSULE;ORAL | 090595-001 | Apr 11, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-001 | Dec 31, 1993 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
