DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 088440
The generic ingredient in URECHOLINE is bethanechol chloride. There are eight drug master file entries for this compound. Sixteen 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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