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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Daiichi Sankyo
Farmers Insurance

Generated: June 23, 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 Janssen Pharms, Ortho Mcneil, 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 lactate. There are twenty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the haloperidol lactate profile page.

Summary for NDA: 015923

Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 015923

Suppliers and Packaging for NDA: 015923

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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 Pharms
haloperidol lactate
INJECTABLE;INJECTION015923-001Approved Prior to Jan 1, 19823,438,991► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission
US Army
Cantor Fitzgerald

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