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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 two 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. Twenty-one suppliers are listed for this compound. Additional details are available on the bethanechol chloride profile page.

Summary for NDA: 088441

Tradename:
URECHOLINE
Applicant:
Odyssey Pharms
Ingredient:
bethanechol chloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Pliva 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 29, 1984TE:AARLD:Yes


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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.

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