Urso Forte - 58914-790-10 - (Ursodiol)

Alphabetical Index


Drug Information of Urso Forte

Product NDC: 58914-790
Proprietary Name: Urso Forte
Non Proprietary Name: Ursodiol
Active Ingredient(s): 500    mg/1 & nbsp;   Ursodiol
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Urso Forte

Product NDC: 58914-790
Labeler Name: Aptalis Pharma US, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020675
Marketing Category: NDA
Start Marketing Date: 19971210

Package Information of Urso Forte

Package NDC: 58914-790-10
Package Description: 100 TABLET, FILM COATED in 1 BOTTLE (58914-790-10)

NDC Information of Urso Forte

NDC Code 58914-790-10
Proprietary Name Urso Forte
Package Description 100 TABLET, FILM COATED in 1 BOTTLE (58914-790-10)
Product NDC 58914-790
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Ursodiol
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 19971210
Marketing Category Name NDA
Labeler Name Aptalis Pharma US, Inc.
Substance Name URSODIOL
Strength Number 500
Strength Unit mg/1
Pharmaceutical Classes Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]

Complete Information of Urso Forte


General Information