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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
Fish and Richardson

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018701

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NDA 018701 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-four suppliers are listed for this compound. Additional details are available on the haloperidol profile page.
Summary for 018701
Applicant:Janssen Pharms
Ingredient:haloperidol decanoate
Formulation / Manufacturing:see details
Pharmacology for NDA: 018701
Suppliers and Packaging for NDA: 018701
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALDOL haloperidol decanoate INJECTABLE;INJECTION 018701 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals LLC 10147-0921 N 10147-0921-3
HALDOL haloperidol decanoate INJECTABLE;INJECTION 018701 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals LLC 10147-0922 N 10147-0922-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Jan 14, 1986TE:AORLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Jan 31, 1997TE:AORLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim

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