01 18GSK
02 2Johnson & Johnson Innovative Medicine
01 1CAPSULE;ORAL
02 2FCT
03 2Filmtabl
04 2Kaps
05 3TABLET;ORAL
06 2Tablet, film-coated
07 8Blank
01 1DISCN
02 2Originator
03 3RX
04 14Blank
01 1AKEEGA 100 mg /500 mg
02 1AKEEGA 50 mg /500 mg
03 4ZEJULA
04 14Zejula
01 8Australia
02 2Norway
03 2South Africa
04 4Switzerland
05 4USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZEJULA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2017-03-27
Application Number : 208447
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2023-04-26
Application Number : 214876
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Packaging :
Approval Date : 2023-04-26
Application Number : 214876
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 300MG BASE
Packaging :
Approval Date : 2023-04-26
Application Number : 214876
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Zejula
Dosage Form : Tablet, film-coated
Dosage Strength : 100 mg
Packaging : Blisterpakning 56item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Zejula
Dosage Form : Tablet, film-coated
Dosage Strength : 100 mg
Packaging : Blisterpakning 84item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zejula
Dosage Form : Kaps
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zejula
Dosage Form : Kaps
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zejula
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zejula
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : AKEEGA 50 mg /500 mg
Dosage Form : FCT
Dosage Strength : 50mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : AKEEGA 100 mg /500 mg
Dosage Form : FCT
Dosage Strength : 100mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
