General MedicationsORALGeneric
NERATINIB MALEATE
NERATINIB MALEATE
Standard Dose
40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview NERATINIB MALEATE is listed in Drugs@FDA under application 216236 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NERATINIB MALEATE Form and strength TABLET;ORAL - 40MG Sponsor SANDOZ INC Submission history Latest submission status date: 2022-07-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview NERATINIB MALEATE is listed in Drugs@FDA under application 216236 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NERATINIB MALEATE Form and strength TABLET;ORAL - 40MG Sponsor SANDOZ INC Submission history Latest submission status date: 2022-07-05 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.