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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 074703

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NDA 074703 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, Pharmobedient Cnsltg, Roxane, Teva, Vistapharm Llc, Novel Labs Inc, Aiping Pharm Inc, Chartwell Rx, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Sandoz, Schering, Strides Pharma Intl, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in fifty-three NDAs. It is available from thirty-three suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE 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 074703

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Pharmobedient Cnsltg
Ingredient:	metoclopramide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 074703

Antiemetics
Dopamine D2 Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	Oct 31, 1997	TE:		RLD:	No

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