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01 20Pfizer Inc
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01 12CAPSULE;ORAL
02 5Capsule
03 3Hard Capsule
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01 5Approved
02 3Authorized
03 6DISCN
04 6RX
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01 12TALZENNA
02 8Talzenna
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01 3Spain
02 5Sweden
03 12USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.25MG BASE
Packaging :
Approval Date : 2018-10-16
Application Number : 211651
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2018-10-16
Application Number : 211651
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2021-09-20
Application Number : 211651
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.75MG BASE
Packaging :
Approval Date : 2021-09-20
Application Number : 211651
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.1MG BASE
Packaging :
Approval Date : 2023-06-20
Application Number : 211651
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.35MG BASE
Packaging :
Approval Date : 2023-06-20
Application Number : 211651
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.1MG BASE
Packaging :
Approval Date : 2024-03-07
Application Number : 217439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.25MG BASE
Packaging :
Approval Date : 2024-03-07
Application Number : 217439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.35MG BASE
Packaging :
Approval Date : 2024-03-07
Application Number : 217439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-03-07
Application Number : 217439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.75MG BASE
Packaging :
Approval Date : 2024-03-07
Application Number : 217439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TALZENNA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2024-03-07
Application Number : 217439
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Talzenna
Dosage Form : Capsule
Dosage Strength : 0.1mg
Packaging :
Approval Date : 08/01/2024
Application Number : 20230202000018
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Talzenna
Dosage Form : Capsule
Dosage Strength : 0.25mg
Packaging :
Approval Date : 20/06/2019
Application Number : 20180430000048
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Talzenna
Dosage Form : Capsule
Dosage Strength : 0.35mg
Packaging :
Approval Date : 20/06/2025
Application Number : 20241014000134
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Talzenna
Dosage Form : Capsule
Dosage Strength : 0.5mg
Packaging :
Approval Date : 20/06/2025
Application Number : 20241014000141
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Talzenna
Dosage Form : Capsule
Dosage Strength :
Packaging :
Approval Date : 20/06/2019
Application Number : 20180430000055
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Talzenna
Dosage Form : Hard Capsule
Dosage Strength : 1MG
Packaging :
Approval Date : 2019-09-11
Application Number : 1191377005
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Talzenna
Dosage Form : Hard Capsule
Dosage Strength : 0.1MG
Packaging :
Approval Date : 2024-01-15
Application Number : 191377007
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Talzenna
Dosage Form : Hard Capsule
Dosage Strength : 0.25MG
Packaging :
Approval Date : 2019-07-24
Application Number : 1191377001
Regulatory Info : Authorized
Registration Country : Spain