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