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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 040728


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NDA 040728 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.
Summary for 040728
Tradename:BETHANECHOL CHLORIDE
Applicant:Chartwell Rx
Ingredient:bethanechol chloride
Patents:0
Pharmacology for NDA: 040728
Mechanism of ActionCholinergic Muscarinic Agonists
Medical Subject Heading (MeSH) Categories for 040728
Suppliers and Packaging for NDA: 040728
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETHANECHOL CHLORIDE bethanechol chloride TABLET;ORAL 040728 ANDA Chartwell RX, LLC 62135-755 62135-755-90 90 TABLET in 1 BOTTLE (62135-755-90)
BETHANECHOL CHLORIDE bethanechol chloride TABLET;ORAL 040728 ANDA Chartwell RX, LLC 62135-756 62135-756-12 120 TABLET in 1 BOTTLE (62135-756-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 26, 2007TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 26, 2007TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 26, 2007TE:AARLD:No

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