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 |