General MedicationsORALStandard
XERMELO
TELOTRISTAT ETIPRATE
Standard Dose
EQ 250MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview XERMELO is listed in Drugs@FDA under application 208794 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TELOTRISTAT ETIPRATE Form and strength TABLET;ORAL - EQ 250MG BASE Sponsor TERSERA Submission history Latest submission status date: 2022-09-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview XERMELO is listed in Drugs@FDA under application 208794 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TELOTRISTAT ETIPRATE Form and strength TABLET;ORAL - EQ 250MG BASE Sponsor TERSERA Submission history Latest submission status date: 2022-09-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.