New SFDA Drug Approvals

Request Type Drug Type Trade Name Scientific Name Strength Dosage Form Approval Date SFDA Approved Use
Registration New Drug Sibnayal Potassium citrate and potassium hydrogen carbonate 8 mEq Prolonged-release granules SFDA Approved Use
Registration New Drug Sibnayal Potassium citrate and potassium hydrogen carbonate 24 mEq Prolonged-release granules SFDA Approved Use
Registration Generic(Multisource) Drug Tepmetko Tepotinib 225 mg Film-coated tablet SFDA Approved Use
Registration Generic(Multisource) Drug Torrenta Ticagrelor 90 mg Film-coated tablet SFDA Approved Use
Registration New Drug TIBSOVO Ivosidenib 250 mg Film-coated tablet SFDA Approved Use
Registration Generic(Multisource) Drug Domito Dorzolamide Hydrochloride Timolol Maleate 2%, 0.5% Eye drops, solution SFDA Approved Use
Registration Generic(Multisource) Drug Tamosymp Tamsulosin Hydrochloride 0.4 mg Modified-release capsule, hard SFDA Approved Use
Registration New Drug MONUROL Fosfomycin 3 g Granules SFDA Approved Use
Registration New Drug Pyrukynd Mitapivat 100 mg Film-coated tablet SFDA Approved Use
Registration Generic(Multisource) Drug Calcium Folinate Hainan Calcium Folinate 500 mg Powder for solution for injection SFDA Approved Use