Orange Book product · Generic (ANDA)
PHENYTOIN SODIUM
PHENYTOIN SODIUM
At a glance
Mar 17, 1987
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 1987
39 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYTOIN SODIUM
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 089521
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
- —DILANTINBrand (NDA)
NDA 010151 · PARKE DAVIS
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ANDA 219773 · MANKIND PHARMA
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ANDA 213834 · UNICHEM
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ANDA 211633 · LUPIN
- 2015EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
ANDA 204309 · AUROBINDO PHARMA
- 2008EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
ANDA 040765 · AMNEAL PHARMS NY
- 2008EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
ANDA 040731 · SUN PHARM INDS
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ANDA 040732 · WOCKHARDT USA
- 2007EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
ANDA 040759 · WOCKHARDT
- 2007PHENYTOIN SODIUMGeneric (ANDA)
ANDA 040781 · AM REGENT
- 2006EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
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.
