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Generated: November 15, 2018

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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-three 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: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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