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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Colorcon
Accenture
Harvard Business School
Cipla
Healthtrust
McKinsey
Johnson and Johnson
Express Scripts
US Army
Fuji

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 015923

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NDA 015923 describes HALDOL, which is a drug marketed by Ortho Mcneil, Janssen Pharms, and Ortho Mcneil Pharm, and is included in five NDAs. It is available from three suppliers. Additional details are available on the HALDOL profile page.

The generic ingredient in HALDOL is haloperidol. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the haloperidol profile page.

Summary for 015923

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 015923

Medical Subject Heading (MeSH) Categories for 015923

Suppliers and Packaging for NDA: 015923

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALDOL haloperidol lactate INJECTABLE;INJECTION 015923 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals LLC 10147-0911 10147-0911-1 10 AMPULE in 1 BOX (10147-0911-1) > 1 mL in 1 AMPULE
HALDOL haloperidol lactate INJECTABLE;INJECTION 015923 NDA Janssen Pharmaceuticals, Inc. 50458-255 50458-255-01 10 AMPULE in 1 BOX (50458-255-01) > 1 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Expired Orange Book Patents for NDA: 015923

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsHALDOLhaloperidol lactateINJECTABLE;INJECTION015923-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Deloitte
Healthtrust
QuintilesIMS
Moodys
Daiichi Sankyo
Teva
Boehringer Ingelheim
Novartis
Medtronic
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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