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Generated: January 23, 2019

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Details for New Drug Application (NDA): 089095

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NDA 089095 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. Fifteen suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.
Summary for 089095
Applicant:Odyssey Pharms
Ingredient:bethanechol chloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 089095
Medical Subject Heading (MeSH) Categories for 089095
Suppliers and Packaging for NDA: 089095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URECHOLINE bethanechol chloride TABLET;ORAL 089095 ANDA Teva Pharmaceuticals USA, Inc. 50111-323 50111-323-01 100 TABLET in 1 BOTTLE (50111-323-01)
URECHOLINE bethanechol chloride TABLET;ORAL 089095 ANDA Teva Women's Health, Inc. 51285-697 51285-697-02 100 TABLET in 1 BOTTLE (51285-697-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 19, 1985TE:AARLD:No

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