Details for New Drug Application (NDA): 006536
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NDA 006536 describes URECHOLINE, which is a drug marketed by Odyssey Pharms and is included in five NDAs. Additional details are available on the URECHOLINE profile page.
The generic ingredient in URECHOLINE is bethanechol chloride. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.
The generic ingredient in URECHOLINE is bethanechol chloride. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.
Summary for 006536
| Tradename: | URECHOLINE |
| Applicant: | Odyssey Pharms |
| Ingredient: | bethanechol chloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 006536
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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