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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040518

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NDA 040518 describes BETHANECHOL CHLORIDE, which is a drug marketed by Able, Actavis Elizabeth, Amneal Pharm, Ascot, Eci Pharms Llc, 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-seven NDAs. It is available from seventeen 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. Nineteen suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.
Summary for 040518
Tradename:BETHANECHOL CHLORIDE
Applicant:Wockhardt
Ingredient:bethanechol chloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040518
Medical Subject Heading (MeSH) Categories for 040518
Suppliers and Packaging for NDA: 040518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETHANECHOL CHLORIDE bethanechol chloride TABLET;ORAL 040518 ANDA Wockhardt Limited 55648-968 E 55648-968-01
BETHANECHOL CHLORIDE bethanechol chloride TABLET;ORAL 040518 ANDA Wockhardt USA LLC. 64679-968 N 64679-968-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 29, 2003TE:AARLD:No

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