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01 1Alembic Pharmaceuticals Limited
02 10AstraZeneca
03 1Intas Pharmaceuticals
04 1MSN Laboratories
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01 1CAP
02 2CAPSULE
03 2CAPSULE;ORAL
04 1Caps
05 1Film-Coated Tablets
06 1Hard Capsule
07 1TABLET;ORAL
08 4Blank
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01 1Originator
02 2RX
03 10Blank
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01 2ACALABRUTINIB
02 7CALQUENCE
03 2Calquence
04 1Calquence 100 mg
05 1Blank
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01 4Australia
02 1Canada
03 1India
04 1South Africa
05 2Switzerland
06 4USA
Regulatory Info :
Registration Country : USA
Brand Name : ACALABRUTINIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 216775
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CALQUENCE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date : 2017-10-31
Application Number : 210259
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CALQUENCE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2022-08-03
Application Number : 216387
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Calquence
Dosage Form : Caps
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Calquence
Dosage Form : Film-Coated Tablets
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Canada
Brand Name : CALQUENCE
Dosage Form : CAPSULE
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 2491788
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : CALQUENCE
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : CALQUENCE
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : CALQUENCE
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : CALQUENCE
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Calquence 100 mg
Dosage Form : CAP
Dosage Strength : 100mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : USA
Brand Name : ACALABRUTINIB
Dosage Form : CAPSULE
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 216833
Regulatory Info :
Registration Country : USA