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QuintilesIMS
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Fish and Richardson
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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017577

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NDA 017577 describes DITROPAN, which is a drug marketed by Ortho Mcneil Janssen and Janssen Pharms and is included in three NDAs. Additional details are available on the DITROPAN profile page.

The generic ingredient in DITROPAN is oxybutynin chloride. There are sixteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 017577
Tradename:DITROPAN
Applicant:Janssen Pharms
Ingredient:oxybutynin chloride
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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