Details for New Drug Application (NDA): 040855
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NDA 040855 describes BETHANECHOL CHLORIDE, which is a drug marketed by Able, Actavis Elizabeth, Amneal Pharm, Ascot, Chartwell Rx, Heritage Pharma, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lannett Co Inc, Sandoz, Sun Pharm Inds Inc, Upsher Smith Labs, Watson Labs, and Wockhardt, and is included in forty-four NDAs. It is available from six suppliers. Additional details are available on the BETHANECHOL CHLORIDE profile page.
The generic ingredient in BETHANECHOL CHLORIDE 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 BETHANECHOL CHLORIDE 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 040855
| Tradename: | BETHANECHOL CHLORIDE |
| Applicant: | Amneal Pharm |
| Ingredient: | bethanechol chloride |
| Patents: | 0 |
Pharmacology for NDA: 040855
| Mechanism of Action | Cholinergic Muscarinic Agonists |
Medical Subject Heading (MeSH) Categories for 040855
Suppliers and Packaging for NDA: 040855
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETHANECHOL CHLORIDE | bethanechol chloride | TABLET;ORAL | 040855 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-571 | 53746-571-01 | 100 TABLET in 1 BOTTLE (53746-571-01) |
| BETHANECHOL CHLORIDE | bethanechol chloride | TABLET;ORAL | 040855 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-572 | 53746-572-01 | 100 TABLET in 1 BOTTLE (53746-572-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 21, 2007 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 21, 2007 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Nov 21, 2007 | TE: | AA | RLD: | No | ||||
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