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Generated: December 18, 2017

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 Holdings Inc, Sandoz, Sun Pharm Inds Inc, Upsher-smith Labs, Watson Labs, and Wockhardt, and is included in forty-seven NDAs. It is available from nineteen 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. Twenty-one suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.

Summary for 040518

Tradename:1
Applicant:1
Ingredient:1
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 55648-968-01 100 TABLET in 1 BOTTLE (55648-968-01)
BETHANECHOL CHLORIDE bethanechol chloride TABLET;ORAL 040518 ANDA Wockhardt USA LLC. 64679-968 64679-968-01 100 TABLET in 1 BOTTLE (64679-968-01)

Summary for product number 001

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


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