Orange Book product · Brand (NDA)
LESCOL
FLUVASTATIN SODIUM
At a glance
Dec 31, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 1993
32 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUVASTATIN SODIUM
Strength
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 020261
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2000LESCOL XLBrand (NDA)
NDA 021192 · SANDOZ
- 2021FLUVASTATIN SODIUMGeneric (ANDA)
ANDA 209397 · BEIJING
- 2016FLUVASTATIN SODIUMGeneric (ANDA)
ANDA 079011 · TEVA PHARMS USA
- 2015FLUVASTATIN SODIUMGeneric (ANDA)
ANDA 202458 · PHARMOBEDIENT
- 2012FLUVASTATIN SODIUMGeneric (ANDA)
ANDA 078407 · TEVA PHARMS
- 2012FLUVASTATIN SODIUMGeneric (ANDA)
ANDA 090595 · MYLAN PHARMS INC
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.
