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Moodys
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Harvard Business School
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 007961

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NDA 007961 describes BENTYL, which is a drug marketed by Allergan Sales Llc and Aptalis Pharma Us and is included in three NDAs. It is available from one supplier. Additional details are available on the BENTYL profile page.

The generic ingredient in BENTYL is dicyclomine hydrochloride. There are four drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 007961
Tradename:BENTYL
Applicant:Aptalis Pharma Us
Ingredient:dicyclomine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 007961

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 15, 1984TE:RLD:Yes

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