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01 1Alkem Laboratories
02 2Auro Pharma Inc
03 3Aurobindo Pharma Limited
04 1Bionpharma
05 1Chartwell Pharmaceuticals llc
06 8Eisai
07 18Eisai Inc
08 2Glenmark Pharmaceuticals
09 3Hetero Drugs
10 3Hikma Pharmaceuticals
11 4Lupin Ltd
12 1MSN Laboratories
13 2Micro Labs Limited
14 1ORIFARM GROUP AS
15 2PHARMOBEDIENT
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01 4Antic-calc Tablet, Film Coated
02 9Film Coated Tablet
03 3Oral Suspension
04 1Potion, suspension
05 1Rufinamide 100Mg 10 Units Oral Use
06 1Rufinamide 200Mg 60 Units Oral Use
07 1Rufinamide 400Mg 60 Units Oral Use
08 9SUSPENSION;ORAL
09 5TABLET
10 18TABLET;ORAL
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01 4Allowed
02 4Approved
03 4Authorized
04 1DISCN
05 5Prescription
06 26RX
07 8Blank
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01 2AURO-RUFINAMIDE
02 7BANZEL
03 20Inovelon
04 23RUFINAMIDE
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01 5Canada
02 3Italy
03 5Norway
04 4Spain
05 4Sweden
06 4Switzerland
07 27USA
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 : 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Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 : 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 : 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 : 2016-05-16
Application Number : 205095
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF