FDA Orange Book · active-ingredient family
Felbamate
Felbamate 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:FELBATOL · NDA 020189
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FELBATOLRLD×3 | MYLAN SPECIALITY LP | NDA 020189 | — | Jul 29, 1993 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FELBAMATE | NOVITIUM PHARMA | ANDA 211333 | AB | May 31, 2019 | |
| FELBAMATE | TARO | ANDA 206314 | AB | Jun 16, 2017 | |
| FELBAMATE×2 | ZYDUS LIFESCIENCES | ANDA 208970 | AB | May 30, 2017 | |
| FELBAMATE×2 | TARO | ANDA 207093 | AB | Apr 20, 2017 | |
| FELBAMATE×2 | ALVOGEN | ANDA 204595 | — | Jan 11, 2016 | |
| FELBAMATE×2 | ANI PHARMS | ANDA 202284 | AB | Nov 04, 2015 | |
| FELBAMATE | AMNEAL PHARMS | ANDA 202385 | AB | Dec 16, 2011 | |
| FELBAMATE×2 | AMNEAL PHARMS | ANDA 201680 | AB | Sep 13, 2011 |
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.
Felbamate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
