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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 077878

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NDA 077878 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-one 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-five suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 077878

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Strides Pharma Intl
Ingredient:	metoclopramide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 077878

Antiemetics
Dopamine D2 Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Aug 28, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 28, 2006	TE:	AB	RLD:	No

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