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UBS
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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011552

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NDA 011552 describes STELAZINE, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the STELAZINE profile page.

The generic ingredient in STELAZINE is trifluoperazine hydrochloride. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.
Summary for 011552
Tradename:STELAZINE
Applicant:Glaxosmithkline
Ingredient:trifluoperazine hydrochloride
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 011552

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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;ORALStrengthEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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;ORALStrengthEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
QuintilesIMS
Daiichi Sankyo
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