Orange Book product · Brand (NDA)
LESCOL XL
FLUVASTATIN SODIUM
At a glance
Oct 06, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 06, 2000
26 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUVASTATIN SODIUM
Strength
EQ 80MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021192
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1993LESCOLBrand (NDA)
NDA 020261 · NOVARTIS
- 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.
