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Cantor Fitzgerald
Federal Trade Commission
Fuji
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040636

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NDA 040636 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 fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.
Summary for 040636
Tradename:BETHANECHOL CHLORIDE
Applicant:Upsher-smith Labs
Ingredient:bethanechol chloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040636
Medical Subject Heading (MeSH) Categories for 040636
Suppliers and Packaging for NDA: 040636
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETHANECHOL CHLORIDE bethanechol chloride TABLET;ORAL 040636 ANDA Upsher-Smith Laboratories, LLC 0832-0513 N 0832-0513-00
BETHANECHOL CHLORIDE bethanechol chloride TABLET;ORAL 040636 ANDA Upsher-Smith Laboratories, LLC 0832-0513 N 0832-0513-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 1, 2005TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Baxter
Accenture
US Army
Chinese Patent Office
Deloitte
Boehringer Ingelheim
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Cipla

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