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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Johnson and Johnson
Fuji
Moodys
US Army
Cipla
Baxter
Boehringer Ingelheim

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090801

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NDA 090801 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 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 090801
Tradename:URSODIOL
Applicant:Glenmark Generics
Ingredient:ursodiol
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090801
Ingredient-typeBile Acids and Salts
Suppliers and Packaging for NDA: 090801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol TABLET;ORAL 090801 ANDA Glenmark Pharmaceuticals Inc., USA 68462-473 N 68462-473-01
URSODIOL ursodiol TABLET;ORAL 090801 ANDA Glenmark Pharmaceuticals Inc., USA 68462-473 N 68462-473-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 12, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 12, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Merck
Queensland Health
Colorcon
QuintilesIMS
Argus Health
Deloitte
US Army
Chubb

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