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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 200854

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NDA 200854 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 200854

Tradename:	HALOPERIDOL
Applicant:	Actavis Group
Ingredient:	haloperidol
Patents:	0

Medical Subject Heading (MeSH) Categories for 200854

Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Dopamine Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Jul 1, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 1, 2022	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jul 1, 2022	TE:		RLD:	No

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