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Details for New Drug Application (NDA): 040721

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NDA 040721 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: 040721

Impax Labs
bethanechol chloride

Pharmacology for NDA: 040721

Suppliers and Packaging for NDA: 040721

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bethanechol chloride
TABLET;ORAL 040721 ANDA Global Pharmaceuticals, Division of Impax Laboratories, Inc. 0115-9544 0115-9544-01 100 TABLET in 1 BOTTLE (0115-9544-01)
bethanechol chloride
TABLET;ORAL 040721 ANDA Global Pharmaceuticals, Division of Impax Laboratories, Inc. 0115-9544 0115-9544-02 500 TABLET in 1 BOTTLE (0115-9544-02)

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Nov 1, 2006TE:RLD:No

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