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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 078347

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NDA 078347 describes HALOPERIDOL, which is a drug marketed by Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon Research, SCS, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, Actavis Group, Aiping Pharm Inc, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Duramed Pharms Barr, Innogenix, Lederle, Mankind Pharma, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Strides Pharma Intl, Zydus Pharms Usa, Caplin, Gland, Hospira, Meitheal, Sandoz, Somerset Theraps Llc, Zydus Pharms, and Actavis Mid Atlantic, and is included in one hundred and eight NDAs. It is available from thirty suppliers. Additional details are available on the HALOPERIDOL profile page.

The generic ingredient in HALOPERIDOL is haloperidol decanoate. There are twenty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.

Summary for 078347

Tradename:	HALOPERIDOL
Applicant:	Mylan Labs Ltd
Ingredient:	haloperidol lactate
Patents:	0

Pharmacology for NDA: 078347

Suppliers and Packaging for NDA: 078347

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	078347	ANDA	Henry Schein, Inc.	0404-9871	0404-9871-01	1 VIAL in 1 BAG (0404-9871-01) / 1 mL in 1 VIAL
HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	078347	ANDA	Cardinal Health 107, LLC	55154-7076	55154-7076-5	5 VIAL in 1 BAG (55154-7076-5) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Sep 14, 2009	TE:	AP	RLD:	No

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