Orange Book product · Generic (ANDA)
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
At a glance
Apr 26, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 2021
5 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUVASTATIN SODIUM
Strength
EQ 80MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 209397
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUVASTATIN SODIUM
- 2000LESCOL XLBrand (NDA)
NDA 021192 · SANDOZ
- 1993LESCOLBrand (NDA)
NDA 020261 · NOVARTIS
- 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.
