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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Mallinckrodt
Fish and Richardson
Fuji
UBS
Baxter
Cerilliant
Deloitte
McKesson

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075517

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NDA 075517 describes URSODIOL, which is a drug marketed by Epic Pharma, Impax Labs Inc, Lannett Co Inc, Mylan, Teva Pharms, Glenmark Generics, Par Pharm, and Teva Pharms Usa, and is included in nine NDAs. It is available from eighteen 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-three suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 075517
Tradename:URSODIOL
Applicant:Epic Pharma
Ingredient:ursodiol
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075517
Ingredient-typeBile Acids and Salts
Suppliers and Packaging for NDA: 075517
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol CAPSULE;ORAL 075517 ANDA Major Pharmaceuticals 0904-6221 N 0904-6221-06
URSODIOL ursodiol CAPSULE;ORAL 075517 ANDA Major Pharmaceuticals 0904-6221 N 0904-6221-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Mar 14, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Baxter
Chinese Patent Office
Chubb
Queensland Health
Harvard Business School
Healthtrust
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