Orange Book product · Generic (ANDA)
FOSPHENYTOIN SODIUM
FOSPHENYTOIN SODIUM
At a glance
Dec 02, 2009
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 02, 2009
16 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
FOSPHENYTOIN SODIUM
Strength
EQ 50MG PHENYTOIN NA/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 078765
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FOSPHENYTOIN SODIUM
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NDA 210864 · LUPIN
- 1996CEREBYXBrand (NDA)
NDA 020450 · PARKE DAVIS
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ANDA 214926 · GLAND
- 2010FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 078736 · PHARMOBEDIENT
- 2010FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 090099 · AM REGENT
- 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
- 2007FOSPHENYTOIN SODIUMGeneric (ANDA)
ANDA 077481 · HIKMA
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.
