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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHB2100041 BPI-23314片 BPI-23314 Tablet Chemical Drugs(1) Supplementary Application 2021-03-11 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd In Review 2022-01-27 view
JXHL2100082 ATG-016片 Tablet Chemical Drugs(1) Import Drug Application 2021-03-05 上海德琪医药科技有限公司 Shanghai Deqi Pharmaceutical Technology Co Ltd;Karyopharm Therapeutics Inc In Review 2022-01-27 view
CXHB2100035 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2022-01-27 view
JYHB2100184 多种油脂肪乳注射液(C6~24) Injection Chemical Drugs Supplementary Application 2021-03-09 费森尤斯卡比华瑞制药有限公司 Fresenius Kabi SSPC;Fresenius Kabi Austria GmbH In Review 2022-01-27 view
CXHB2100057 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(原1.1) Supplementary Application 2021-04-10 百济神州(北京)生物科技有限公司 BeiGene (Beijing) Co Ltd In Review 2022-01-27 view
JYHB2100182 多种油脂肪乳注射液(C6~24) Injection Chemical Drugs Supplementary Application 2021-03-09 费森尤斯卡比华瑞制药有限公司 Fresenius Kabi SSPC;Fresenius Kabi Austria GmbH In Review 2022-01-27 view
JYHB2100183 多种油脂肪乳注射液(C6~24) Injection Chemical Drugs Supplementary Application 2021-03-09 费森尤斯卡比华瑞制药有限公司 Fresenius Kabi SSPC;Fresenius Kabi Austria GmbH In Review 2022-01-27 view
CXHB2100042 BPI-23314片 BPI-23314 Tablet Chemical Drugs(1) Supplementary Application 2021-03-11 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd In Review 2022-01-27 view
CXHB2100037 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2022-01-27 view
CXHB2100036 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2022-01-27 view
CXHB2100038 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2022-01-27 view
CXHS2000047 替戈拉生片 tegoprazan Tablet Chemical Drugs(1) New Drug Application 2021-01-14 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd In Review 2022-01-19 view
CXHS2000002 ZL-2401对甲苯磺酸盐片 omadacycline tosylate Tablet Chemical Drugs(1) New Drug Application 2020-02-14 上海宣泰海门药业有限公司,再鼎医药(上海)有限公司 Haimen PHARMA INC;Zai Lab (Shanghai) Co Ltd Certificate Issued 2021-12-17 view
JXHS2100013 ATG-010片 Selinexor Tablet Chemical Drugs(5.1) Import Drug Application 2021-01-28 德琪(浙江)医药科技有限公司 Antengene Corporation Co Ltd;Catalent Cts LLC;Karyopharm Therapeutics Inc Certificate Issued 2021-12-17 view
CXHS2000003 注射用ZL-2401对甲苯磺酸盐 omadacycline tosylate Lyophilized Chemical Drugs(1) New Drug Application 2020-02-14 浙江海正药业股份有限公司,再鼎医药(上海)有限公司 Zhejiang Hisun Pharmaceutical Co Ltd;Zai Lab (Shanghai) Co Ltd Certificate Issued 2021-12-17 view
CXSS2100032 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(2.2) New Drug Application 2021-03-26 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd Certificate Completed-Pending Issued 2021-12-10 view
CXSS2100031 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(2.2) New Drug Application 2021-03-26 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd Certificate Completed-Pending Issued 2021-12-10 view
CYHB2100192 复方氨基酸注射液(18AA-V-SF) alanine;Arginine hydrochloride;aspartic acid;cysteine hydrochloride;glutamic acid;glycine;histidine hydrochloride;isoleucine;leucine;Lysine Hydrochloride;Methionone;phenylalanine;proline;serine;threon Injection Chemical Drugs Supplementary Application 2021-01-28 湖北一半天制药有限公司 Hubei Banbantian Pharmaceutical Co Ltd Certificate Issued 2021-11-05 view
CYHB2100193 复方氨基酸注射液(18AA-V-SF) alanine;Arginine hydrochloride;aspartic acid;cysteine hydrochloride;glutamic acid;glycine;histidine hydrochloride;isoleucine;leucine;Lysine Hydrochloride;Methionone;phenylalanine;proline;serine;threon Injection Chemical Drugs Supplementary Application 2021-01-28 湖北一半天制药有限公司 Hubei Banbantian Pharmaceutical Co Ltd Certificate Issued 2021-11-05 view
CYHB2100191 复方氨基酸注射液(18AA-V-SF) alanine;Arginine hydrochloride;aspartic acid;cysteine hydrochloride;glutamic acid;glycine;histidine hydrochloride;isoleucine;leucine;Lysine Hydrochloride;Methionone;phenylalanine;proline;serine;threon Injection Chemical Drugs Supplementary Application 2021-01-28 湖北一半天制药有限公司 Hubei Banbantian Pharmaceutical Co Ltd Certificate Issued 2021-11-05 view