Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Teva
Dow
McKinsey
Daiichi Sankyo
Farmers Insurance
UBS
US Department of Justice
Medtronic
Fuji
Chubb

Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079082

« Back to Dashboard
NDA 079082 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 six 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: 079082

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 079082

Ingredient-typeBile Acids and Salts

Suppliers and Packaging for NDA: 079082

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL
ursodiol
CAPSULE;ORAL 079082 ANDA Lannett Company, Inc. 0527-1326 0527-1326-01 100 CAPSULE in 1 BOTTLE (0527-1326-01)
URSODIOL
ursodiol
CAPSULE;ORAL 079082 ANDA Major Pharmaceuticals 0904-6483 0904-6483-60 100 CAPSULE in 1 BOTTLE (0904-6483-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Dec 15, 2008TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
Healthtrust
Baxter
Chubb
AstraZeneca
Cantor Fitzgerald
Cerilliant
Johnson and Johnson
Colorcon
McKesson

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot