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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYHB2400677 卡谷氨酸分散片 carglumic acid Tablet Chemical Drugs(5.1) Supplementary Application 2024-12-25 Recordati Rare Diseases Inc;Laboratoires BTT view
JYHB2400169 卡谷氨酸分散片 carglumic acid Tablet Chemical Drugs(5.1) Supplementary Application 2024-04-18 Recordati Rare Diseases Inc;Laboratoires BTT view
JYHB2300670 卡谷氨酸分散片 carglumic acid Tablet Chemical Drugs(5.1) Supplementary Application 2023-11-21 Recordati Rare Diseases Inc;Laboratoires BTT view
JYHS2300062 卡谷氨酸片 carglumic acid Tablet Chemical Drugs(5.2) Import Drug Application 2023-06-02 Apothecon Pharmaceuticals Pvt Ltd;Jiedi Pharmaceutical Technology (Shanghai) Co Ltd;Waymade PLC view
CYHS2200940 卡谷氨酸片 carglumic acid Tablet Chemical Drugs(3) Generic Drug 2022-06-23 GRAND Pharmaceutical (CHINA) Co Ltd view
JXHS2200032 卡谷氨酸分散片 carglumic acid Tablet Chemical Drugs(5.1) Import Drug Application 2022-03-29 Recordati Rare Diseases Inc;Recordati (Beijing) Pharmaceutical Co Ltd;Laboratoires BTT view
JTH2100677 卡谷氨酸分散片 carglumic acid Tablet Chemical Drugs Disposable Import Drug Application 2021-10-27 Recordati Rare Diseases Inc;Laboratoires BTT;Hangzhou Tigermed Consulting Co Ltd view
CYHS1700638 卡谷氨酸片 carglumic acid Tablet Chemical Drugs(3) Generic Drug 2018-06-28 远大医药(中国)有限公司 GRAND Pharmaceutical (CHINA) Co Ltd In Review 2018-06-26 view
CYHS1700637 卡谷氨酸 carglumic acid Active ingredient Chemical Drugs(3) Generic Drug 2018-06-28 武汉武药制药有限公司 Wuhan Wuyao Pharmaceutical Co Ltd In Review 2018-06-26 view