FDA Orange Book · active-ingredient family
Fluvastatin sodium
Fluvastatin sodium is approved as 2 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LESCOL XL · NDA 021192
2
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LESCOL XLRLD | SANDOZ | NDA 021192 | AB | Oct 06, 2000 | |
| LESCOLRLD×2 | NOVARTIS | NDA 020261 | — | Dec 31, 1993 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUVASTATIN SODIUM | BEIJING | ANDA 209397 | AB | Apr 26, 2021 | |
| FLUVASTATIN SODIUM | TEVA PHARMS USA | ANDA 079011 | AB | Jan 27, 2016 | |
| FLUVASTATIN SODIUM | PHARMOBEDIENT | ANDA 202458 | — | Sep 11, 2015 | |
| FLUVASTATIN SODIUM×2 | TEVA PHARMS | ANDA 078407 | AB | Jun 12, 2012 | |
| FLUVASTATIN SODIUM×2 | MYLAN PHARMS INC | ANDA 090595 | AB | Apr 11, 2012 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Fluvastatin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
