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    Acalabrutinib

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    Alembic Pharmaceuticals Limited

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    Alembic Pharmaceuticals Limited

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    ACALABRUTINIB

    Brand Name : ACALABRUTINIB

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 100MG

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    Application Number : 216775

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    Registration Country : USA

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    Acalabrutinib

    Brand Name : ACALAKAST

    Dosage Form : Capsule

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    03

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    Regulatory Info : RX

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    ACALABRUTINIB

    Brand Name : CALQUENCE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2017-10-31

    Application Number : 210259

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

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    ACALABRUTINIB MALEATE

    Brand Name : CALQUENCE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 100MG BASE

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    Approval Date : 2022-08-03

    Application Number : 216387

    Regulatory Info : RX

    Registration Country : USA

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    05

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Acalabrutinib

    Brand Name : Calquence

    Dosage Form : Hard Capsule

    Dosage Strength : 100mg

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    Approval Date : 2021-03-04

    Application Number : 67790

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    06

    AstraZeneca

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Acalabrutinib

    Brand Name : Calquence

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

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    Approval Date : 2023-05-04

    Application Number : 68817

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    07

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    Regulatory Info :

    Registration Country : Moldova

    Acalabrutinib

    Brand Name : Calquence

    Dosage Form : Film Coated Tablet

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    Approval Date : 01-07-2024

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    Regulatory Info :

    Registration Country : Moldova

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    08

    AstraZeneca

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    Regulatory Info : Not Marketed

    Registration Country : Norway

    Akalabrutinib

    Brand Name : Calquence

    Dosage Form : Capsule

    Dosage Strength : 100mg

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    Approval Date :

    Application Number :

    Regulatory Info : Not Marketed

    Registration Country : Norway

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    09

    AstraZeneca

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    Regulatory Info : Marketed

    Registration Country : Norway

    Akalabrutinib

    Brand Name : Calquence

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

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    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    10

    AstraZeneca

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Acalabrutinib

    Brand Name : Calquence

    Dosage Form : Capsule

    Dosage Strength : 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    11

    AstraZeneca

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Acalabrutinib

    Brand Name : Calquence

    Dosage Form : Film-Coated Tablet

    Dosage Strength : 100mg

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    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    12

    AstraZeneca

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    Regulatory Info : Authorized

    Registration Country : Spain

    Acalabrutinib Maleate

    Brand Name : Calquence

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 21-06-2023

    Application Number : 1201479004

    Regulatory Info : Authorized

    Registration Country : Spain

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    13

    AstraZeneca

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    Regulatory Info : Authorized

    Registration Country : Spain

    Acalabrutinib

    Brand Name : Calquence

    Dosage Form : Hard Capsule

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 18-11-2020

    Application Number : 1201479002

    Regulatory Info : Authorized

    Registration Country : Spain

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    14

    AstraZeneca

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    AstraZeneca

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    Regulatory Info : Authorized

    Registration Country : Spain

    Acalabrutinib Maleate

    Brand Name : Calquence

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 09-09-2025

    Application Number : 1201479004IP

    Regulatory Info : Authorized

    Registration Country : Spain

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    15

    AstraZeneca

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Acalabrutinib Maleate

    Brand Name : Calquence

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 21-03-2023

    Application Number : 28106702621

    Regulatory Info : Prescription

    Registration Country : Denmark

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    16

    AstraZeneca

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Acalabrutinib

    Brand Name : Calquence

    Dosage Form : Hard Capsules

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 05-11-2020

    Application Number : 28106346219

    Regulatory Info : Prescription

    Registration Country : Denmark

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    17

    AstraZeneca

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    Regulatory Info : Approved

    Registration Country : Sweden

    Acalabrutinib

    Brand Name : Calquence

    Dosage Form : Capsule

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 05-11-2020

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    18

    Genex Pharma

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    Genex Pharma

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    Registration Country : India

    ACALABRUTINIB CAPSULES

    Brand Name : CAPBRUSAM

    Dosage Form : Capsule

    Dosage Strength : 100MG

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    Registration Country : India

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    19

    Intas Pharmaceuticals

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    Intas Pharmaceuticals

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    Registration Country : India

    Acalabrutinib

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    Dosage Form : Hard Capsule

    Dosage Strength : 100MG

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    Approval Date :

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    Regulatory Info :

    Registration Country : India

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    MSN Laboratories

    India
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    MSN Laboratories

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    Regulatory Info :

    Registration Country : USA

    ACALABRUTINIB

    Brand Name : ACALABRUTINIB

    Dosage Form : CAPSULE

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 216833

    Regulatory Info :

    Registration Country : USA

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