Gimoti

NDA 209388, held by Qol Medcl. Metoclopramide Hydrochloride.

As of Nov 13, 2026, NDA 209388 (Gimoti), held by Qol Medcl, was first approved by FDA on Jun 19, 2020, with 2 approved supplements and 1 published complete response letter.

First approved: Jun 19, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 19, 2020	Original applicationTYPE 3/4 · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Apr 1, 2019	Gimoti (metoclopramide nasal spray)Clinical Pharmacology, Product Quality/Device Quality	Approved

Products

1 strengths and forms

Product	Active ingredient	Marketing
GimotiEQ 15MG BASE/SPRAY · spray, metered;nasal	Metoclopramide Hydrochloride	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Feb 9, 2026	Supplement 4Labeling · Standard review	Approved	Label Medication Guide Letter
Jan 14, 2021	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 19, 2020	Original applicationTYPE 3/4 · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 209388
Drugs@FDA: Overview at FDA
Company: QOL Medical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters