Details for New Drug Application (NDA): 007961
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The generic ingredient in BENTYL is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-five 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 |
Medical Subject Heading (MeSH) Categories for 007961
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 15, 1984 | TE: | RLD: | Yes |
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