01 1Alembic Pharmaceuticals Limited
02 10AstraZeneca
03 1Intas Pharmaceuticals
01 1CAP
02 1CAPSULE
03 2CAPSULE;ORAL
04 1Caps
05 1Film-Coated Tablets
06 1Hard Capsule
07 1TABLET;ORAL
08 4Blank
01 1Originator
02 1Prescription
03 2RX
04 8Blank
01 1ACALABRUTINIB
02 7CALQUENCE
03 2Calquence
04 1Calquence 100 mg
05 1Blank
01 4Australia
02 1Canada
03 1India
04 1South Africa
05 2Switzerland
06 3USA
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 : Prescription
Registration Country : Canada
Brand Name : CALQUENCE
Dosage Form : CAPSULE
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 2491788
Regulatory Info : Prescription
Registration Country : Canada
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 : 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 :
Registration Country : India
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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