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FDA NDA · NDA209388

GIMOTI

metoclopramide hydrochloride

Sponsor: QOL MEDCL

APPLICATION
NDA209388
TYPE
NDA
ORIGINAL APPROVAL
2020-06-19
LATEST ACTION
2026-02-09
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

GIMOTI · ReferencePrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 15MG BASE/SPRAY · SPRAY, METERED · NASAL

Approval history

2026-02-09Labeling · Supplement 4 · standard — Letter ↗AP
2021-01-14Labeling · Supplement 1 · standard — Label ↗AP
2020-06-19Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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