Orange Book product · Generic (ANDA)
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
Generic (ANDA)ANDA 078407TE ABRX TEVA PHARMS
At a glance
Jun 12, 2012
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 2012
14 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUVASTATIN SODIUM
Strength
EQ 20MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 078407
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
- 2021FLUVASTATIN SODIUMGeneric (ANDA)
ANDA 209397 · BEIJING
- 2016FLUVASTATIN SODIUMGeneric (ANDA)
ANDA 079011 · TEVA PHARMS USA
- 2015FLUVASTATIN SODIUMGeneric (ANDA)
ANDA 202458 · PHARMOBEDIENT
- 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.
