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Last Updated: June 22, 2021

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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 two 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. Nineteen suppliers are listed for this compound. Additional details are available on the haloperidol profile page.
Summary for 015923
Applicant:Janssen Pharms
Ingredient:haloperidol lactate
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
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

Profile for product number 001

Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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