Details for New Drug Application (NDA): 008732
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NDA 008732 describes PRO-BANTHINE, which is a drug marketed by Gd Searle Llc and Shire and is included in two NDAs. Additional details are available on the PRO-BANTHINE profile page.
The generic ingredient in PRO-BANTHINE is propantheline bromide. There are seven drug master file entries for this compound. Additional details are available on the propantheline bromide profile page.
The generic ingredient in PRO-BANTHINE is propantheline bromide. There are seven drug master file entries for this compound. Additional details are available on the propantheline bromide profile page.
Summary for 008732
| Tradename: | PRO-BANTHINE |
| Applicant: | Shire |
| Ingredient: | propantheline bromide |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 008732
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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