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Generated: May 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040533

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NDA 040533 describes BETHANECHOL CHLORIDE, which is a drug marketed by Lannett, Watson Labs, Lannett Holdings Inc, Able, Wockhardt, Impax Labs, Pharmax, Upsher Smith, Actavis Elizabeth, Sandoz, Amneal Pharm, Heritage Pharma, Ascot, Ivax Sub Teva Pharms, and Sun Pharm Inds Inc, and is included in fifty 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 NDA: 040533

Formulation / Manufacturing:see details

Pharmacology for NDA: 040533

Suppliers and Packaging for NDA: 040533

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bethanechol chloride
TABLET;ORAL 040533 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2557 0615-2557-39 30 TABLET in 1 BLISTER PACK (0615-2557-39)
bethanechol chloride
TABLET;ORAL 040533 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2558 0615-2558-39 30 TABLET in 1 BLISTER PACK (0615-2558-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 29, 2003TE:AARLD:No

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