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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078347

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NDA 078347 describes HALOPERIDOL, which is a drug marketed by Alpharma, Morton Grove, Pharm Assoc, SCS, Silarx, Teva, Teva Pharms, Abraxis Pharm, Akorn, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Anda Repository, Cycle Pharms Ltd, Duramed Pharms Barr, Lederle, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sandoz, Vintage, Zydus Pharms Usa, Hospira, Sandoz Inc, and Actavis Mid Atlantic, and is included in one hundred and six NDAs. It is available from twenty-eight 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. Seven 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
Therapeutic Class:	Antipsychotics
Formulation / Manufacturing:	see details

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	General Injectables and Vaccines, Inc.	52584-426	N	52584-426-00
HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	078347	ANDA	Cardinal Health	55154-7076	N	55154-7076-5

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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Serving hundreds of leading biopharmaceutical companies globally:

Julphar

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Healthtrust

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McKinsey

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Covington

Harvard Business School

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