Details for New Drug Application (NDA): 091256
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NDA 091256 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 seven 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.
Summary for 091256
| Tradename: | BETHANECHOL CHLORIDE |
| Applicant: | Heritage Pharma |
| Ingredient: | bethanechol chloride |
| Patents: | 0 |
Pharmacology for NDA: 091256
| Mechanism of Action | Cholinergic Muscarinic Agonists |
Medical Subject Heading (MeSH) Categories for 091256
Suppliers and Packaging for NDA: 091256
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETHANECHOL CHLORIDE | bethanechol chloride | TABLET;ORAL | 091256 | ANDA | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-934 | 23155-934-01 | 100 TABLET in 1 BOTTLE (23155-934-01) |
| BETHANECHOL CHLORIDE | bethanechol chloride | TABLET;ORAL | 091256 | ANDA | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-935 | 23155-935-01 | 100 TABLET in 1 BOTTLE (23155-935-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 4, 2010 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 4, 2010 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 4, 2010 | TE: | AA | RLD: | No | ||||
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