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Details for New Drug Application (NDA): 200826

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NDA 200826 describes URSODIOL, which is a drug marketed by Glenmark Generics, Epic Pharma, Impax Labs Inc, Mylan, Par Pharm, Lannett, Teva Pharms Usa, Teva Pharms, and Corepharma, 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 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: 200826

Tradename:
URSODIOL
Applicant:
Impax Labs Inc
Ingredient:
ursodiol
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 200826

Ingredient-typeBile Acids and Salts

Suppliers and Packaging for NDA: 200826

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL
ursodiol
TABLET;ORAL 200826 ANDA Global Pharmaceuticals, Division of Impax Laboratories, Inc. 0115-1524 0115-1524-01 100 TABLET, FILM COATED in 1 BOTTLE (0115-1524-01)
URSODIOL
ursodiol
TABLET;ORAL 200826 ANDA Global Pharmaceuticals, Division of Impax Laboratories, Inc. 0115-1525 0115-1525-01 100 TABLET, FILM COATED in 1 BOTTLE (0115-1525-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 23, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 23, 2011TE:ABRLD:No


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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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