General MedicationsORALStandard
TEPMETKO
TEPOTINIB HYDROCHLORIDE
Standard Dose
EQ 225MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TEPMETKO is listed in Drugs@FDA under application 214096 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TEPOTINIB HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 225MG BASE Sponsor EMD SERONO INC Submission history Latest submission status date: 2024-02-15 00:00:00.
Structured Monograph
Clinical summary
Approval overview TEPMETKO is listed in Drugs@FDA under application 214096 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TEPOTINIB HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 225MG BASE Sponsor EMD SERONO INC Submission history Latest submission status date: 2024-02-15 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.