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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Citi
Baxter
Julphar
Novartis
Medtronic
McKesson
QuintilesIMS
Cantor Fitzgerald
Merck

Generated: January 16, 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, 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-six 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 0904-6221-06 50 BLISTER PACK in 1 CARTON (0904-6221-06) > 1 CAPSULE in 1 BLISTER PACK
URSODIOL ursodiol CAPSULE;ORAL 075517 ANDA Major Pharmaceuticals 0904-6221 0904-6221-61 100 BLISTER PACK in 1 CARTON (0904-6221-61) > 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Dow
Chubb
Mallinckrodt
Farmers Insurance
Deloitte
Covington
Cipla
Harvard Business School
Federal Trade Commission

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