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Last Updated: August 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 015921

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NDA 015921 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. Eighteen suppliers are listed for this compound. Additional details are available on the haloperidol profile page.
Summary for 015921
Tradename:HALDOL
Applicant:Ortho Mcneil
Ingredient:haloperidol
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 015921

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 015921

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-006 Feb 2, 1982   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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