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01 5Zenara Pharma
02 19Angelini Pharma
03 10ENDO OPERATIONS LTD.
04 3ORIFARM GROUP AS
05 6SK Life Science
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01 17Film Coated Tablet
02 2KIT
03 13TABLET
04 6TABLET;ORAL
05 2Tablet
06 3Tablet, film-coated
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01 7Allowed
02 5Approved
03 7Authorized
04 10Prescription
05 6RX
06 8Blank
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01 5CENOBAMATE
02 3Ontozory
03 19Ontozry
04 16XCOPRI
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01 10Canada
02 3Norway
03 7Spain
04 5Sweden
05 7Switzerland
06 11USA
Regulatory Info :
Registration Country : USA
Brand Name : CENOBAMATE
Dosage Form : TABLET
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number : 219403
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : CENOBAMATE
Dosage Form : TABLET
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number : 219403
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : CENOBAMATE
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 219403
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : CENOBAMATE
Dosage Form : TABLET
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number : 219403
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : CENOBAMATE
Dosage Form : TABLET
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number : 219403
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ontozry
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 26/03/2021
Application Number : 20200312000055
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ontozry
Dosage Form : Film Coated Tablet
Dosage Strength : 150mg
Packaging :
Approval Date : 26/03/2021
Application Number : 20200312000062
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ontozry
Dosage Form : Film Coated Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 26/03/2021
Application Number : 20200312000079
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ontozry
Dosage Form : Film Coated Tablet
Dosage Strength : 25mg;12.5mg
Packaging :
Approval Date : 26/03/2021
Application Number : 20200312000024
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ontozry
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Approval Date : 26/03/2021
Application Number : 20200312000048
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Ontozry
Dosage Form : Tablet
Dosage Strength : 12.5mg
Packaging :
Approval Date : 19/05/2022
Application Number : 68051
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info :
Registration Country : Norway
Brand Name : Ontozory
Dosage Form : Tablet, film-coated
Dosage Strength : 200 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Ontozory
Dosage Form : Tablet, film-coated
Dosage Strength : 150 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Ontozory
Dosage Form : Tablet, film-coated
Dosage Strength : 50 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
Brand Name : XCOPRI
Dosage Form : TABLET;ORAL
Dosage Strength : 12.5MG
Packaging :
Approval Date : 2020-03-10
Application Number : 212839
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XCOPRI
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG
Packaging :
Approval Date : 2020-03-10
Application Number : 212839
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XCOPRI
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Packaging :
Approval Date : 2020-03-10
Application Number : 212839
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XCOPRI
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date : 2020-03-10
Application Number : 212839
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XCOPRI
Dosage Form : TABLET;ORAL
Dosage Strength : 150MG
Packaging :
Approval Date : 2020-03-10
Application Number : 212839
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XCOPRI
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2020-03-10
Application Number : 212839
Regulatory Info : RX
Registration Country : USA