Orange Book product · Brand (NDA)
DILANTIN-125
PHENYTOIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PHENYTOIN
Strength
125MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 008762
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2014PHENYTOINGeneric (ANDA)
ANDA 040884 · EPIC PHARMA LLC
- 2014PHENYTOINGeneric (ANDA)
ANDA 200565 · TARO
- 2012PHENYTOINGeneric (ANDA)
ANDA 200691 · RISING
- 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.
