Orange Book product · Brand (NDA)
BANZEL
RUFINAMIDE
At a glance
Nov 14, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2008
17 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
RUFINAMIDE
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021911
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2011BANZELBrand (NDA)
NDA 201367 · EISAI INC
- 2025RUFINAMIDEGeneric (ANDA)
ANDA 214817 · MSN
- 2023RUFINAMIDEGeneric (ANDA)
ANDA 216841 · HETERO LABS LTD III
- 2023RUFINAMIDEGeneric (ANDA)
ANDA 217230 · AUROBINDO PHARMA
- 2023RUFINAMIDEGeneric (ANDA)
ANDA 216688 · MICRO LABS
- 2022RUFINAMIDEGeneric (ANDA)
ANDA 214009 · CHARTWELL RX
- 2022RUFINAMIDEGeneric (ANDA)
ANDA 216549 · AUROBINDO PHARMA
- 2022RUFINAMIDEGeneric (ANDA)
ANDA 204964 · LUPIN
- 2021RUFINAMIDEGeneric (ANDA)
ANDA 204993 · HETERO LABS LTD III
- 2021RUFINAMIDEGeneric (ANDA)
ANDA 213410 · ALKEM LABS LTD
- 2020RUFINAMIDEGeneric (ANDA)
ANDA 213457 · LUPIN
- 2019RUFINAMIDEGeneric (ANDA)
ANDA 211388 · BIONPHARMA
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.
