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Generated: May 20, 2019

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Details for New Drug Application (NDA): 088441

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NDA 088441 describes URECHOLINE, which is a drug marketed by Odyssey Pharms and is included in five NDAs. It is available from three suppliers. Additional details are available on the URECHOLINE profile page.

The generic ingredient in URECHOLINE is bethanechol chloride. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.
Summary for 088441
Applicant:Odyssey Pharms
Ingredient:bethanechol chloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 088441
Medical Subject Heading (MeSH) Categories for 088441
Suppliers and Packaging for NDA: 088441
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URECHOLINE bethanechol chloride TABLET;ORAL 088441 ANDA Teva Pharmaceuticals USA, Inc. 50111-325 50111-325-01 100 TABLET in 1 BOTTLE (50111-325-01)
URECHOLINE bethanechol chloride TABLET;ORAL 088441 ANDA Teva Women's Health, Inc. 51285-691 51285-691-02 100 TABLET in 1 BOTTLE (51285-691-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 29, 1984TE:AARLD:No

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