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Last Updated: March 22, 2023

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 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. Twenty suppliers are listed for this compound. Additional details are available on the haloperidol profile page.

Summary for 018701

Tradename:	HALDOL
Applicant:	Janssen Pharms
Ingredient:	haloperidol decanoate
Patents:	0
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	10147-0921-3	3 AMPULE in 1 BOX (10147-0921-3) / 1 mL in 1 AMPULE
HALDOL	haloperidol decanoate	INJECTABLE;INJECTION	018701	NDA AUTHORIZED GENERIC	Patriot Pharmaceuticals LLC	10147-0922	10147-0922-5	5 AMPULE in 1 BOX (10147-0922-5) / 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	Jan 14, 1986	TE:	AO	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/ML
Approval Date:	Jan 31, 1997	TE:	AO	RLD:	Yes

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Serving leading biopharmaceutical companies globally:

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