FDA Orange Book · active-ingredient family
Ethosuximide
Ethosuximide is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZARONTIN · NDA 012380
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZARONTINRLD | PARKE DAVIS | NDA 012380 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ETHOSUXIMIDE | PURACAP PHARM LLC | ANDA 210654 | AB | Mar 16, 2020 | |
| ETHOSUXIMIDE | ONESOURCE SPECIALTY | ANDA 211928 | AB | Feb 19, 2019 | |
| ETHOSUXIMIDE | HERITAGE PHARMS INC | ANDA 200892 | — | Sep 25, 2012 | |
| ETHOSUXIMIDE | EPIC PHARMA LLC | ANDA 040686 | AB | May 28, 2008 | |
| ETHOSUXIMIDE | CHARTWELL RX | ANDA 040506 | AA | Dec 22, 2003 | |
| ETHOSUXIMIDE | BIONPHARMA | ANDA 040430 | AB | Oct 28, 2002 | |
| ETHOSUXIMIDE | PHARM ASSOC | ANDA 040253 | AA | Nov 22, 2000 | |
| ETHOSUXIMIDE | TEVA PHARMS | ANDA 081306 | — | Jul 30, 1993 | |
| ZARONTINRLD | PARKE-DAVIS | ANDA 080258 | AA | 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.
Ethosuximide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
