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Generated: November 18, 2018

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Details for New Drug Application (NDA): 088440

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NDA 088440 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 088440
Tradename:URECHOLINE
Applicant:Odyssey Pharms
Ingredient:bethanechol chloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 088440
Medical Subject Heading (MeSH) Categories for 088440
Suppliers and Packaging for NDA: 088440
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URECHOLINE bethanechol chloride TABLET;ORAL 088440 ANDA Teva Pharmaceuticals USA, Inc. 50111-324 50111-324-01 100 TABLET in 1 BOTTLE (50111-324-01)
URECHOLINE bethanechol chloride TABLET;ORAL 088440 ANDA Teva Women's Health, Inc. 51285-690 51285-690-02 100 TABLET in 1 BOTTLE (51285-690-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 29, 1984TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Fish and Richardson
Harvard Business School
Johnson and Johnson
Daiichi Sankyo
Covington
Julphar
Cantor Fitzgerald
Farmers Insurance

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