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01 1Key Oncologics
02 1Pierre Fabre
03 1Puma Biotechnology
04 1Sandoz B2B
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01 1FCT
02 1Film Coated Tablet
03 2TABLET;ORAL
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01 1Authorized
02 1Originator
03 1RX
04 1Blank
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01 1NERATINIB MALEATE
02 1NERLYNX
03 2Nerlynx
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01 1South Africa
02 1Spain
03 2USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Nerlynx
Dosage Form : FCT
Dosage Strength : 40mg
Packaging : 180X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Nerlynx
Dosage Form : Film Coated Tablet
Dosage Strength : 40MG
Packaging :
Approval Date : 2020-01-07
Application Number : 1181311001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : RX
Registration Country : USA
Brand Name : NERLYNX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 40MG BASE
Packaging :
Approval Date : 2017-07-17
Application Number : 208051
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : NERATINIB MALEATE
Dosage Form : TABLET;ORAL
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number : 216236
Regulatory Info :
Registration Country : USA