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. Thirty-two 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

Pharmacology for NDA: 209388

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 209388

Antiemetics
Dopamine D2 Receptor Antagonists

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:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	EQ 15MG BASE/SPRAY
Approval Date:	Jun 19, 2020	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 22, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
Patent:	⤷ Sign Up	Patent Expiration:	Dec 22, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
Patent:	⤷ Sign Up	Patent Expiration:	Dec 22, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS

Expired US Patents for NDA 209388

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Evoke Pharma Inc	GIMOTI	metoclopramide hydrochloride	SPRAY, METERED;NASAL	209388-001	Jun 19, 2020	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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