Last Updated: September 24, 2026

Details for New Drug Application (NDA): 084353

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NDA 084353 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.

Summary for 084353

Tradename:	BETHANECHOL CHLORIDE
Applicant:	Sandoz
Ingredient:	bethanechol chloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 084353

Muscarinic Agonists
Parasympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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