Orange Book product · Generic (ANDA)
PHENYTOIN
PHENYTOIN
At a glance
Apr 19, 2002
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 19, 2002
24 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYTOIN
Strength
125MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 040420
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PHENYTOIN
- —DILANTIN-125Brand (NDA)
NDA 008762 · VIATRIS
- 2014PHENYTOINGeneric (ANDA)
ANDA 040884 · EPIC PHARMA LLC
- 2014PHENYTOINGeneric (ANDA)
ANDA 200565 · TARO
- 2012PHENYTOINGeneric (ANDA)
ANDA 200691 · RISING
- 2004PHENYTOINGeneric (ANDA)
ANDA 040521 · TARO
- 2001PHENYTOINGeneric (ANDA)
ANDA 040342 · VISTAPHARM LLC
- 1992PHENYTOINGeneric (ANDA)
ANDA 089892 · ACTAVIS MID ATLANTIC
- —DILANTINGeneric (ANDA)
ANDA 084427 · PHARMACIA
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.
