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Urso 250
Urso 250 - 58914-785-10 - (Ursodiol)
Drug Information of Urso 250
| Product NDC: | 58914-785 |
| Proprietary Name: | Urso 250 |
| Non Proprietary Name: | Ursodiol |
| Active Ingredient(s): | 250 mg/1 & nbsp; Ursodiol |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Urso 250
| Product NDC: | 58914-785 |
| 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 250
| Package NDC: | 58914-785-10 |
| Package Description: | 100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10) |
NDC Information of Urso 250
| NDC Code | 58914-785-10 |
| Proprietary Name | Urso 250 |
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10) |
| Product NDC | 58914-785 |
| 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 | 250 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |
