Orange Book product · Generic (ANDA)
FOSPHENYTOIN SODIUM
FOSPHENYTOIN SODIUM
At a glance
Aug 06, 2007
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 06, 2007
19 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
FOSPHENYTOIN SODIUM
Strength
EQ 50MG PHENYTOIN NA/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 078158
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FOSPHENYTOIN SODIUM
- 2020SESQUIENTBrand (NDA)
NDA 210864 · LUPIN
- 1996CEREBYXBrand (NDA)
NDA 020450 · PARKE DAVIS
- 2023FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 214926 · GLAND
- 2010FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 078736 · PHARMOBEDIENT
- 2010FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 090099 · AM REGENT
- 2009FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 078765 · HIKMA FARMACEUTICA
- 2008FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 078476 · AMNEAL
- 2008FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 078417 · SUN PHARM
- 2007FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 078277 · AM REGENT
- 2007FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 078126 · APOTEX INC
- 2007FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 076886 · DR REDDYS
- 2007FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 078052 · FRESENIUS KABI USA
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.
