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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 216004

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NDA 216004 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 216004

Tradename:	HALOPERIDOL
Applicant:	Msn
Ingredient:	haloperidol
Patents:	0

Pharmacology for NDA: 216004

Medical Subject Heading (MeSH) Categories for 216004

Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Dopamine Antagonists

Suppliers and Packaging for NDA: 216004

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOPERIDOL	haloperidol	TABLET;ORAL	216004	ANDA	Novadoz Pharmaceuticals LLC	72205-064	72205-064-91	100 TABLET in 1 BOTTLE (72205-064-91)
HALOPERIDOL	haloperidol	TABLET;ORAL	216004	ANDA	Novadoz Pharmaceuticals LLC	72205-064	72205-064-99	1000 TABLET in 1 BOTTLE (72205-064-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Nov 18, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 18, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Nov 18, 2022	TE:	AB	RLD:	No

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