Details for New Drug Application (NDA): 007409
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NDA 007409 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-five 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-five suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 007409
| Tradename: | BENTYL |
| Applicant: | Allergan |
| Ingredient: | dicyclomine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 007409
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 15, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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