General MedicationsORALStandard
GILOTRIF
AFATINIB DIMALEATE
Standard Dose
EQ 30MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview GILOTRIF is listed in Drugs@FDA under application 201292 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient AFATINIB DIMALEATE Form and strength TABLET;ORAL - EQ 30MG BASE Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2022-04-07 00:00:00.
Structured Monograph
Clinical summary
Approval overview GILOTRIF is listed in Drugs@FDA under application 201292 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient AFATINIB DIMALEATE Form and strength TABLET;ORAL - EQ 30MG BASE Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2022-04-07 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.