General MedicationsNASALStandard
GIMOTI
METOCLOPRAMIDE HYDROCHLORIDE
Standard Dose
EQ 15MG BASE/SPRAY
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GIMOTI is listed in Drugs@FDA under application 209388 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient METOCLOPRAMIDE HYDROCHLORIDE Form and strength SPRAY, METERED;NASAL - EQ 15MG BASE/SPRAY Sponsor QOL MEDCL Submission history Latest submission status date: 2026-02-09 00:00:00.
Structured Monograph
Clinical summary
Approval overview GIMOTI is listed in Drugs@FDA under application 209388 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METOCLOPRAMIDE HYDROCHLORIDE Form and strength SPRAY, METERED;NASAL - EQ 15MG BASE/SPRAY Sponsor QOL MEDCL Submission history Latest submission status date: 2026-02-09 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.