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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 209388


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NDA 209388 describes GIMOTI, which is a drug marketed by Evoke Pharma Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the GIMOTI profile page.

The generic ingredient in GIMOTI is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 209388
Tradename:GIMOTI
Applicant:Evoke Pharma Inc
Ingredient:metoclopramide hydrochloride
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 209388
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 209388
Suppliers and Packaging for NDA: 209388
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GIMOTI metoclopramide hydrochloride SPRAY, METERED;NASAL 209388 NDA Evoke Pharma, Inc. 72089-307 72089-307-15 1 BOTTLE, PUMP in 1 CARTON (72089-307-15) / 9.8 mL in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 15MG BASE/SPRAY
Approval Date:Jun 19, 2020TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 22, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
Patent:⤷  Try a TrialPatent Expiration:Dec 22, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
Patent:⤷  Try a TrialPatent Expiration:Dec 22, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS

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