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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Argus Health
US Department of Justice
Fuji
Deloitte
Cantor Fitzgerald
Harvard Business School
Cipla
Covington
Dow

Generated: June 24, 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 Glenmark Generics, Epic Pharma, Impax Labs Inc, Mylan, Par Pharm, Lannett, Teva Pharms Usa, and Teva Pharms, 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 five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

Summary for NDA: 202540

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 49884-412-01 100 TABLET, FILM COATED in 1 BOTTLE (49884-412-01)
URSODIOL
ursodiol
TABLET;ORAL 202540 ANDA Par Pharmaceutical, Inc. 49884-412 49884-412-05 500 TABLET, FILM COATED in 1 BOTTLE (49884-412-05)

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 500+ biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Medtronic
UBS
McKesson
Chinese Patent Office
Deloitte
Moodys
Fish and Richardson
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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