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Last Updated: November 4, 2024

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. Twenty-two suppliers are listed for this compound. Additional details are available on the haloperidol profile page.
Summary for 015923
Tradename:HALDOL
Applicant:Janssen Pharms
Ingredient:haloperidol lactate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 015923

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms HALDOL haloperidol lactate INJECTABLE;INJECTION 015923-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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