Details for New Drug Application (NDA): 007961
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NDA 007961 describes BENTYL, which is a drug marketed by Allergan, Abbvie, and Aptalis Pharma Us, and is included in three NDAs. It is available from two suppliers. 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. Fifty-four suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
The generic ingredient in BENTYL is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-four 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| Dosage: | SYRUP;ORAL | Strength | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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