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Johnson and Johnson
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Chinese Patent Office
Express Scripts

Generated: March 22, 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-five suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 075517
Applicant:Epic Pharma
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:

US Department of Justice
Argus Health
Federal Trade Commission
Queensland Health

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