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Details for New Drug Application (NDA): 088440
NDA 088440 describes URECHOLINE, which is a drug marketed by Odyssey Pharms and is included in five NDAs. It is available from two suppliers. 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.
Summary for 088440
| Tradename: | URECHOLINE |
| Applicant: | Odyssey Pharms |
| Ingredient: | bethanechol chloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088440
| Mechanism of Action | Cholinergic Muscarinic Agonists |
Medical Subject Heading (MeSH) Categories for 088440
Suppliers and Packaging for NDA: 088440
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| URECHOLINE | bethanechol chloride | TABLET;ORAL | 088440 | ANDA | Teva Pharmaceuticals USA, Inc. | 50111-324 | N | 50111-324-01 |
| URECHOLINE | bethanechol chloride | TABLET;ORAL | 088440 | ANDA | Teva Women's Health, Inc. | 51285-690 | N | 51285-690-02 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 29, 1984 | TE: | AA | RLD: | No | ||||
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