FDA Orange Book · active-ingredient family
Phenytoin
Phenytoin is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DILANTIN-125 · NDA 008762
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DILANTIN-125RLD×2 | VIATRIS | NDA 008762 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHENYTOIN | EPIC PHARMA LLC | ANDA 040884 | AB | Nov 28, 2014 | |
| PHENYTOIN | TARO | ANDA 200565 | AB | Apr 17, 2014 | |
| PHENYTOIN | RISING | ANDA 200691 | AB | Dec 26, 2012 | |
| PHENYTOIN | TARO | ANDA 040521 | AB | Mar 08, 2004 | |
| PHENYTOIN | PAI HOLDINGS PHARM | ANDA 040420 | — | Apr 19, 2002 | |
| PHENYTOIN×2 | VISTAPHARM LLC | ANDA 040342 | — | Jan 31, 2001 | |
| PHENYTOIN | ACTAVIS MID ATLANTIC | ANDA 089892 | — | Sep 25, 1992 | |
| DILANTINRLD | PHARMACIA | ANDA 084427 | AB | Approved Prior to Jan 1, 1982 |
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.
Phenytoin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
