Orange Book product · Generic (ANDA)
PHENYTOIN SODIUM
PHENYTOIN SODIUM
At a glance
May 31, 1985
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 1985
41 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYTOIN SODIUM
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 089003
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PHENYTOIN SODIUM
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ANDA 040765 · AMNEAL PHARMS NY
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ANDA 040731 · SUN PHARM INDS
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ANDA 040732 · WOCKHARDT USA
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ANDA 040759 · WOCKHARDT
- 2007PHENYTOIN SODIUMGeneric (ANDA)
ANDA 040781 · AM REGENT
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ANDA 040621 · SUN PHARM INDS (IN)
- 2006PHENYTOIN SODIUMGeneric (ANDA)
ANDA 040573 · ACELLA
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.
