Orange Book product · Generic (ANDA)
FOSPHENYTOIN SODIUM
FOSPHENYTOIN SODIUM
At a glance
Aug 06, 2007
Approved
Generic (ANDA)
Application
AP
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
AP
Application
ANDA 077481
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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ANDA 090099 · AM REGENT
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ANDA 078765 · HIKMA FARMACEUTICA
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ANDA 078476 · AMNEAL
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ANDA 078417 · SUN PHARM
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ANDA 078277 · AM REGENT
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ANDA 078126 · APOTEX INC
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ANDA 076886 · DR REDDYS
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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.
