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Serving leading biopharmaceutical companies globally:

Moodys
Fish and Richardson
Daiichi Sankyo
Boehringer Ingelheim
Chinese Patent Office
Mallinckrodt
Johnson and Johnson
Cerilliant
Teva
Fuji

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019594

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NDA 019594 describes ACTIGALL, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from seven suppliers. Additional details are available on the ACTIGALL profile page.

The generic ingredient in ACTIGALL is ursodiol. There are seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 019594
Tradename:ACTIGALL
Applicant:Allergan Sales Llc
Ingredient:ursodiol
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 019594
Ingredient-typeBile Acids and Salts
Suppliers and Packaging for NDA: 019594
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTIGALL ursodiol CAPSULE;ORAL 019594 NDA Allergan, Inc. 0023-6145 N 0023-6145-01
ACTIGALL ursodiol CAPSULE;ORAL 019594 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3159 N 0591-3159-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength150MG
Approval Date:Dec 31, 1987TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Dec 31, 1987TE:ABRLD:Yes

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Covington
Cantor Fitzgerald
UBS
Federal Trade Commission
Baxter
Citi
Merck
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Harvard Business School

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