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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204756

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NDA 204756 describes METOCLOPRAMIDE, which is a drug marketed by Avet Lifesciences, 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-five NDAs. It is available from three suppliers. Additional details are available on the METOCLOPRAMIDE profile page.

The generic ingredient in METOCLOPRAMIDE 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 204756

Tradename:	METOCLOPRAMIDE
Applicant:	Avet Lifesciences
Ingredient:	metoclopramide hydrochloride
Patents:	0

Pharmacology for NDA: 204756

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 204756

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 204756

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	204756	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-240	23155-240-41	25 VIAL in 1 CARTON (23155-240-41) / 2 mL in 1 VIAL (23155-240-31)
METOCLOPRAMIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	204756	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-240	23155-240-42	25 VIAL in 1 CARTON (23155-240-42) / 10 mL in 1 VIAL (23155-240-32)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Dec 20, 2013	TE:	AP	RLD:	No

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