Urso Forte - Ursodiol
Navigation: NDC > Supplier starting with: A > APTALIS PHARMA US, INC.| Field | Value |
|---|---|
| NDC Code: | 58914-790 |
| Proprietary Name: | Urso Forte |
| Suffix: | |
| Non-Proprietary Name: | Ursodiol |
| Dosage Form: | TABLET, FILM COATED |
| Method: | ORAL |
| Original Marketing Date: | 10-12-1997 |
| Category Name: | NDA |
| Application Number: | NDA020675 |
| Labeler: | APTALIS PHARMA US, INC. |
| Substance Name: | URSODIOL |
| Active Numerator Strength: | 500 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |
| DEA Schedule: |