Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
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01 2Lee Fine Chem
02 4Centocor
03 6Janssen-Cilag
04 3Johnson & Johnson Innovative Medicine
05 1Zydus Lifesciences
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01 1FCT
02 6Film Coated Tablet
03 2TABLET
04 3TABLET;ORAL
05 2Tablet
06 2Blank
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01 2Allowed
02 2Approved
03 2Authorized
04 1Originator
05 2Prescription
06 3RX
07 4Blank
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01 1APALUTAMIDE
02 2Apalutamide
03 5ERLEADA
04 6Erleada
05 2Erlyand
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01 2Australia
02 2Canada
03 2India
04 1South Africa
05 2Spain
06 2Sweden
07 2Switzerland
08 3USA
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
Regulatory Info :
Registration Country : India
Brand Name : Apalutamide
Dosage Form : Tablet
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
Regulatory Info :
Registration Country : India
Brand Name : Apalutamide
Dosage Form : Tablet
Dosage Strength : 240MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ERLEADA
Dosage Form : TABLET;ORAL
Dosage Strength : 60MG
Packaging :
Approval Date : 2018-02-14
Application Number : 210951
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ERLEADA
Dosage Form : TABLET;ORAL
Dosage Strength : 240MG
Packaging :
Approval Date : 2023-02-17
Application Number : 210951
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ERLEADA
Dosage Form : TABLET
Dosage Strength : 60MG
Packaging : 56/120
Approval Date :
Application Number : 2478374
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ERLEADA
Dosage Form : TABLET
Dosage Strength : 240MG
Packaging :
Approval Date :
Application Number : 2540185
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Erleada
Dosage Form : Film Coated Tablet
Dosage Strength : 240mg
Packaging :
Approval Date : 25/08/2023
Application Number : 20221110000061
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Erleada
Dosage Form : Film Coated Tablet
Dosage Strength : 60mg
Packaging :
Approval Date : 14/01/2019
Application Number : 20180209000026
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Erleada
Dosage Form : Film Coated Tablet
Dosage Strength : 60mg
Packaging :
Approval Date : 19/09/2019
Application Number : 67072
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Erleada
Dosage Form : Film Coated Tablet
Dosage Strength : 240mg
Packaging :
Approval Date : 19/09/2019
Application Number : 67072
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Erleada
Dosage Form : Film Coated Tablet
Dosage Strength : 240MG
Packaging :
Approval Date : 2023-08-30
Application Number : 1181342004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Erleada
Dosage Form : Film Coated Tablet
Dosage Strength : 60MG
Packaging :
Approval Date : 2019-02-04
Application Number : 1181342001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : ERLEADA
Dosage Form : FCT
Dosage Strength : 60mg
Packaging : 120X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Erlyand
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Erlyand
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : APALUTAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 60MG
Packaging :
Approval Date : 2025-03-17
Application Number : 217113
Regulatory Info : RX
Registration Country : USA