FDA Orange Book · active-ingredient family
Phenytoin sodium
Phenytoin sodium is approved as 1 brand and 33 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DILANTIN · NDA 010151
1
Brand (NDA)
33
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DILANTIN | PARKE DAVIS | NDA 010151 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (33)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXTENDED PHENYTOIN SODIUM | MANKIND PHARMA | ANDA 219773 | AB | Jan 02, 2026 | |
| EXTENDED PHENYTOIN SODIUM | UNICHEM | ANDA 213834 | — | Oct 13, 2022 | |
| EXTENDED PHENYTOIN SODIUM | LUPIN | ANDA 211633 | — | Sep 30, 2019 | |
| EXTENDED PHENYTOIN SODIUM | AUROBINDO PHARMA | ANDA 204309 | AB | Jun 10, 2015 | |
| EXTENDED PHENYTOIN SODIUM | AMNEAL PHARMS NY | ANDA 040765 | AB | Nov 12, 2008 | |
| EXTENDED PHENYTOIN SODIUM×2 | SUN PHARM INDS | ANDA 040731 | — | Jun 30, 2008 | |
| EXTENDED PHENYTOIN SODIUM | WOCKHARDT USA | ANDA 040732 | — | Jan 30, 2008 | |
| EXTENDED PHENYTOIN SODIUM | WOCKHARDT | ANDA 040759 | — | Dec 18, 2007 | |
| PHENYTOIN SODIUM | AM REGENT | ANDA 040781 | — | Dec 04, 2007 | |
| EXTENDED PHENYTOIN SODIUM | SUN PHARM INDS (IN) | ANDA 040621 | — | Dec 11, 2006 | |
| PHENYTOIN SODIUM | ACELLA | ANDA 040573 | AP | Sep 13, 2006 | |
| EXTENDED PHENYTOIN SODIUM | TARO | ANDA 040684 | AB | Sep 05, 2006 | |
| EXTENDED PHENYTOIN SODIUM | ANI PHARMS | ANDA 040435 | — | Jun 20, 2003 | |
| EXTENDED PHENYTOIN SODIUM×3 | MYLAN | ANDA 040298 | — | Dec 28, 1998 | |
| PHENYTOIN SODIUM | MARSAM PHARMS LLC | ANDA 089779 | — | Nov 27, 1992 | |
| PHENYTOIN SODIUM | WARNER CHILCOTT | ANDA 089900 | — | Mar 30, 1990 | |
| PHENYTOIN SODIUM | HOSPIRA | ANDA 089744 | — | Dec 18, 1987 | |
| PHENYTOIN SODIUM | MARSAM PHARMS LLC | ANDA 089501 | — | Oct 13, 1987 | |
| PHENYTOIN SODIUM | HOSPIRA | ANDA 089521 | — | Mar 17, 1987 | |
| EXTENDED PHENYTOIN SODIUM | ANI PHARMS | ANDA 089441 | — | Dec 18, 1986 | |
| PHENYTOIN SODIUM | FRESENIUS KABI USA | ANDA 089003 | — | May 31, 1985 | |
| PHENYTEX | WATSON LABS | ANDA 088711 | — | Dec 21, 1984 | |
| PHENYTOIN SODIUM | SMITH AND NEPHEW | ANDA 088519 | — | Dec 19, 1984 | |
| PHENYTOIN SODIUM | SMITH AND NEPHEW | ANDA 088521 | — | Dec 18, 1984 | |
| PHENYTOIN SODIUM | SOLOPAK | ANDA 088520 | — | Dec 17, 1984 | |
| DILANTINRLD×2 | VIATRIS | ANDA 084349 | — | Approved Prior to Jan 1, 1982 | |
| DIPHENYLAN SODIUM×2 | CHARTWELL MOLECULAR | ANDA 080857 | — | Approved Prior to Jan 1, 1982 | |
| PHENYTOIN SODIUM | PHARMERAL | ANDA 085435 | — | Approved Prior to Jan 1, 1982 | |
| PHENYTOIN SODIUM | WATSON LABS | ANDA 085894 | — | Approved Prior to Jan 1, 1982 | |
| PROMPT PHENYTOIN SODIUM | ANI PHARMS | ANDA 080259 | — | Approved Prior to Jan 1, 1982 | |
| PROMPT PHENYTOIN SODIUM | WATSON LABS | ANDA 080905 | — | Approved Prior to Jan 1, 1982 | |
| PHENYTOIN SODIUMRLD | HIKMA | ANDA 084307 | AP | Approved Prior to Jan 1, 1982 | |
| PHENYTOIN SODIUM | WATSON LABS | ANDA 085434 | — | 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 sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
