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Serving leading biopharmaceutical companies globally:

Farmers Insurance
US Army
US Department of Justice
Express Scripts
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202540

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NDA 202540 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 202540

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202540

Ingredient-typeBile Acids and Salts

Suppliers and Packaging for NDA: 202540

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol TABLET;ORAL 202540 ANDA Par Pharmaceutical, Inc. 49884-412 49884-412-05 500 TABLET, FILM COATED in 1 BOTTLE (49884-412-05)
URSODIOL ursodiol TABLET;ORAL 202540 ANDA Par Pharmaceutical, Inc. 49884-412 49884-412-01 100 TABLET, FILM COATED in 1 BOTTLE (49884-412-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Feb 14, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Feb 14, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Army
Boehringer Ingelheim
Argus Health

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