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Serving leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Express Scripts

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200826

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NDA 200826 describes URSODIOL, which is a drug marketed by Epic Pharma, Impax Labs Inc, Lannett, Mylan, Teva Pharms, Glenmark Generics, Par Pharm, and Teva Pharms Usa, and is included in nine NDAs. It is available from nineteen suppliers. Additional details are available on the URSODIOL profile page.

The generic ingredient in URSODIOL is ursodiol. There are seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 200826
Applicant:Impax Labs Inc
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200826
Ingredient-typeBile Acids and Salts
Suppliers and Packaging for NDA: 200826
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol TABLET;ORAL 200826 ANDA Impax Generics 0115-1524 N 0115-1524-01
URSODIOL ursodiol TABLET;ORAL 200826 ANDA Impax Generics 0115-1525 N 0115-1525-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 23, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 23, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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