General MedicationsORALStandard
ORSERDU
ELACESTRANT HYDROCHLORIDE
Standard Dose
EQ 345MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ORSERDU is listed in Drugs@FDA under application 217639 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ELACESTRANT HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 345MG BASE Sponsor STEMLINE THERAP Submission history Latest submission status date: 2023-11-09 00:00:00.
Structured Monograph
Clinical summary
Approval overview ORSERDU is listed in Drugs@FDA under application 217639 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ELACESTRANT HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 345MG BASE Sponsor STEMLINE THERAP Submission history Latest submission status date: 2023-11-09 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.