Orange Book product · Generic (ANDA)
RUFINAMIDE
RUFINAMIDE
At a glance
Apr 23, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 23, 2019
7 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
RUFINAMIDE
Strength
40MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 211388
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 204993 · HETERO LABS LTD III
- 2021RUFINAMIDEGeneric (ANDA)
ANDA 213410 · ALKEM LABS LTD
- 2020RUFINAMIDEGeneric (ANDA)
ANDA 213457 · LUPIN
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.
