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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 017862

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NDA 017862 describes REGLAN, which is a drug marketed by Hikma, Robins Ah, Ani Pharms, and Meda Pharms, and is included in four NDAs. It is available from one supplier. Additional details are available on the REGLAN profile page.

The generic ingredient in REGLAN is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 017862

Tradename:	REGLAN
Applicant:	Hikma
Ingredient:	metoclopramide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 017862

Antiemetics
Dopamine D2 Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 28, 1987	TE:		RLD:	No

Expired US Patents for NDA 017862

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-001	Approved Prior to Jan 1, 1982	4,536,386	⤷ Get Started Free
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-004	May 28, 1987	4,536,386	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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