Orange Book product · Generic (ANDA)
PHENYTOIN
PHENYTOIN
At a glance
Dec 26, 2012
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 26, 2012
13 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYTOIN
Strength
50MG
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
AB
Application
ANDA 200691
Product number
001
Marketing status
RX
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
- 2004PHENYTOINGeneric (ANDA)
ANDA 040521 · TARO
- 2002PHENYTOINGeneric (ANDA)
ANDA 040420 · PAI HOLDINGS PHARM
- 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.
