01 1Alkem Laboratories
02 2Auro Pharma Inc
03 3Aurobindo Pharma Limited
04 1Bionpharma
05 1Chartwell Pharmaceuticals llc
06 3Eisai
07 18Eisai Inc
08 2Glenmark Pharmaceuticals
09 3Hetero Drugs
10 3Hikma Pharmaceuticals
11 4Lupin Ltd
12 2Micro Labs Limited
13 1ORIFARM GROUP AS
14 2Viatris
01 4Antic-calc Tablet, Film Coated
02 3FILM COATED PILL
03 2Filmtabl
04 1ORAL SUSPENSION
05 1Potion, suspension
06 1Rufinamide 100Mg 10 Units Oral Use
07 1Rufinamide 200Mg 60 Units Oral Use
08 1Rufinamide 400Mg 60 Units Oral Use
09 8SUSPENSION;ORAL
10 1Susp
11 5TABLET
12 18TABLET;ORAL
01 1DISCN
02 5Prescription
03 25RX
04 15Blank
01 2AURO-RUFINAMIDE
02 7BANZEL
03 15Inovelon
04 22RUFINAMIDE
01 5Canada
02 3Italy
03 5Norway
04 4Sweden
05 3Switzerland
06 26USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2021-02-23
Application Number : 213410
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2022-10-26
Application Number : 216549
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2023-06-16
Application Number : 217230
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2023-06-16
Application Number : 217230
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2019-04-23
Application Number : 211388
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2022-11-07
Application Number : 214009
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BANZEL
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2008-11-14
Application Number : 21911
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BANZEL
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2008-11-14
Application Number : 21911
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BANZEL
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2008-11-14
Application Number : 21911
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BANZEL
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2011-03-03
Application Number : 201367
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Inovelon
Dosage Form : FILM COATED PILL
Dosage Strength : 200 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Inovelon
Dosage Form : FILM COATED PILL
Dosage Strength : 400 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Inovelon
Dosage Form : FILM COATED PILL
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Inovelon
Dosage Form : ORAL SUSPENSION
Dosage Strength : 40 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2016-05-16
Application Number : 205075
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2016-05-16
Application Number : 205075
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2021-05-11
Application Number : 204993
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2021-05-11
Application Number : 204993
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2023-12-05
Application Number : 216841
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2016-05-16
Application Number : 204988
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2016-05-16
Application Number : 204988
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2019-04-23
Application Number : 207363
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date : 2022-08-17
Application Number : 204964
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2022-08-17
Application Number : 204964
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2022-08-17
Application Number : 204964
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2020-12-18
Application Number : 213457
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2023-05-15
Application Number : 216688
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2023-05-15
Application Number : 216688
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2016-05-16
Application Number : 205095
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : RUFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2016-05-16
Application Number : 205095
Regulatory Info : RX
Registration Country : USA
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