Orange Book product · Generic (ANDA)
EXTENDED PHENYTOIN SODIUM
PHENYTOIN SODIUM
At a glance
Jan 02, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 02, 2026
6 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYTOIN SODIUM
Strength
100MG EXTENDED
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 219773
Product number
001
Marketing status
RX
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
- 2022EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
ANDA 213834 · UNICHEM
- 2019EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
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
- 2008EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
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
- 2006EXTENDED PHENYTOIN SODIUMGeneric (ANDA)
ANDA 040684 · TARO
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.
