01 1Key Oncologics
02 1Puma Biotechnology
03 1Sandoz B2B
01 1FCT
02 2TABLET;ORAL
01 1Originator
02 1RX
03 1Blank
01 1NERATINIB MALEATE
02 1NERLYNX
03 1Nerlynx
01 1South Africa
02 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 : 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
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