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Details for New Drug Application (NDA): 040636

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NDA 040636 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-three NDAs. It is available from twenty 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-two suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.

Summary for NDA: 040636

Upsher Smith
bethanechol chloride

Pharmacology for NDA: 040636

Suppliers and Packaging for NDA: 040636

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bethanechol chloride
TABLET;ORAL 040636 ANDA Upsher-Smith Laboratories, Inc. 0832-0513 0832-0513-00 100 TABLET in 1 BOTTLE (0832-0513-00)
bethanechol chloride
TABLET;ORAL 040636 ANDA Upsher-Smith Laboratories, Inc. 0832-0513 0832-0513-01 100 BLISTER PACK in 1 CARTON (0832-0513-01) > 1 TABLET in 1 BLISTER PACK (0832-0513-89)

Summary for product number 001

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.