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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 075858

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NDA 075858 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 075858

Tradename:	HALOPERIDOL
Applicant:	Hikma
Ingredient:	haloperidol lactate
Patents:	0

Pharmacology for NDA: 075858

Suppliers and Packaging for NDA: 075858

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	075858	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9319	0143-9319-25	25 VIAL in 1 BOX (0143-9319-25) / 1 mL in 1 VIAL
HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	075858	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9501	0143-9501-25	25 VIAL in 1 BOX (0143-9501-25) / 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:	Jun 18, 2001	TE:	AP	RLD:	No

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