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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: