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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
H20020201 L-谷氨酰胺 glutamine Active ingredient Chemical Drugs Import Drug Application 2000-01-01 协和发酵工业株式会社北京代表处 Kyowa Hakko Kogyo Co Ltd Beijing;Ube Plant of Kyowa Hakko Kogyo Co Ltd;Kyowa Hakko Kogyo Co Ltd Approval Completed-Pending Certificated view
A20020041 L-门冬氨酸钾 potassium aspartate Active ingredient Chemical Drugs New Drug Application 2003-11-10 曼秀雷敦(中山)药业有限公司 Mentholatum (CHINA) Pharmaceuticals Co Ltd Approval Completed-Pending Certificated view
CXL01C79G 13C-尿素呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs(4) New Drug Application 2002-02-23 北京嘉汇彬医药技术有限公司 Beijing Jiahuibin Pharmaceutical Technology Co Ltd In Approval view
HS20020015 CA15-3 酶免试剂盒 Diagnostic reagent IVD Import Drug Application 2002-04-01 瑞典康乃格生物工程有限公司北京办事处 Approval Completed-Pending Certificated view
BS20020014 注射用重组人红细胞生成素-β Lyophilized Biological Products Import Drug Application 2002-10-29 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
H20020277 复方α-酮酸片 D,L-Hydroxymethionine Calcium;D,L-α-Ketoisoleucine Calcium;histidine;Lysine acetate;threonine;tryptophan;tyrosine;α-Ketoleucine Calcium;α-Ketophenylalanine Calcium;α-Ketovaline Calcium Tablet Chemical Drugs Import Drug Application 2002-11-15 北京费森尤斯卡比医药有限公司 Beijing Fresenius Kabi Pharmaceutical Company Limited Approval Completed-Pending Certificated view
H20020180 5-单硝酸异山犁酯缓释片 isosorbide mononitrate Tablet, extended release Chemical Drugs Import Drug Application 2002-07-25 瑞士大昌洋行(中国)有限公司北京代表处 Approval Completed-Pending Certificated view
CSS00089 抗人白细胞介素-8单克隆抗体乳膏 Mouse Monoclonal Antibody against Human Interleukin-8 Cream Biological Products(1) New Drug Application 2001-03-01 东莞宏远逸士生物技术药业有限公司加拿大YES生物技术研究有限公司 In Approval view
CDS20020009 乳酸脱氢酶液体试剂盒(LDH-L) Diagnostic reagent IVD(2) New Drug Application 2002-06-03 上海复星长征医学科学有限公司 Shanghai Fosun LONG March MEDICAL Science Co Ltd Approval Completed-Pending Certificated view
CXL01342 复方L-谷氨酰胺颗粒剂 Glutamine;Guaiazulene Sulfonate Sodium Granule Chemical Drugs(4) New Drug Application 2001-05-11 黑龙江省澳利达药物研究所 In Approval view
A20020057 d-α-生育酚聚乙二醇1000琥珀酸酯 Active ingredient Chemical Drugs New Drug Application 2003-09-22 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Approval Completed-Pending Certificated view
AS20010005 TNK-组织型纤溶酶原激活剂 Other Biological Products New Drug Application 2001-06-20 勃林格殷格翰国际贸易(上海)有限公司北京办事处 Approval Completed-Pending Certificated view
AS20000033 聚乙二醇干扰素α-2b注射剂 peginterferon alfa-2b Lyophilized Biological Products New Drug Application 2004-02-25 先灵葆雅(中国)有限公司 Schering Plough(China)Co Ltd Approval Completed-Pending Certificated view
H20010286 中/长链脂肪乳注射液(C6-24) Injection Chemical Drugs Import Drug Application 2001-11-23 华瑞制药有限公司 Fresenius Kabi SSPC Approval Completed-Pending Certificated view
CXSL2500416 SHR-7782注射液 Biological Products(1) New Drug Application 2025-05-23 Suzhou Suncadia Biopharmaceuticals Co Ltd view
FS20000002 重组人白细胞介素-2 Recombinant Human Interleukin-2 Lyophilized Biological Products Import Drug Application 2000-01-01 Kento Limitecd Kento Limitecd;Chiron Projects BV In Review view
A20020050 ε-氨基已酰 Active ingredient Chemical Drugs New Drug Application 2003-11-10 曼秀雷敦(中山)药业有限公司 Mentholatum (CHINA) Pharmaceuticals Co Ltd Approval Completed-Pending Certificated view
H20020158 注射用替卡西林钠-克拉维酸钾 potassium clavulanate;ticarcillin sodium Lyophilized Chemical Drugs Import Drug Application 2002-07-08 葛兰素史克有限公司北京办事处 Glaxosmithkline Beijing Approval Completed-Pending Certificated view
A20020049 D-泛酰醇 dexpanthenol Active ingredient Chemical Drugs New Drug Application 2002-05-30 曼秀雷敦(中山)药业有限公司 Mentholatum (CHINA) Pharmaceuticals Co Ltd Approval Completed-Pending Certificated view
H20020099 碳13-尿素呼吸试剂 Diagnostic reagent Chemical Drugs Import Drug Application 2002-04-22 美国普特股份有限公司(北京代表处) Approval Completed-Pending Certificated view