Orange Book product · Generic (ANDA)
RUFINAMIDE
RUFINAMIDE
At a glance
May 11, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 11, 2021
5 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
RUFINAMIDE
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 204993
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RUFINAMIDE
- 2011BANZELBrand (NDA)
NDA 201367 · EISAI INC
- 2008BANZELBrand (NDA)
NDA 021911 · 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 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.
