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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL1100292 MDV3100胶囊 enzalutamide Capsule Chemical Drugs Import Drug Application 2011-08-29 Medivation, Inc. Medivation Inc Certificate Issued 2013-01-30 view
JXHL1200344 MDV3100胶囊 enzalutamide Capsule Chemical Drugs Import Drug Application 2012-10-30 Astellas Pharma Inc. Astellas Pharma Inc Certificate Issued 2013-07-09 view
JXHL1300312 MDV3100胶囊 enzalutamide Capsule Chemical Drugs Import Drug Application 2013-08-19 安斯泰来制药(中国)有限公司 Astellas Pharmaceutical (China) Co Ltd Certificate Issued 2014-07-24 view
CXHL1400304 恩杂鲁胺 enzalutamide Active ingredient Chemical Drugs(3.1) New Drug Application 2014-04-02 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-02-18 view
CXHL1400305 恩杂鲁胺软胶囊 enzalutamide Soft capsules Chemical Drugs(3.1) New Drug Application 2014-04-03 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-02-29 view
CXHL1500016 恩杂鲁胺 enzalutamide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-01-27 南京海纳医药科技有限公司 Nanjing Healthnice Pharmaceutical Technology Co Ltd Certificate Issued 2016-05-19 view
CXHL1500017 恩杂鲁胺软胶囊 enzalutamide Soft capsules Chemical Drugs(3.1) New Drug Application 2015-01-27 南京海纳医药科技有限公司 Nanjing Healthnice Pharmaceutical Technology Co Ltd Certificate Issued 2016-05-12 view
CXHL1500217 恩杂鲁胺 enzalutamide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-02-26 连云港润众制药有限公司 Lianyungang Runzhong Pharmaceutical Co Ltd Certificate Issued 2016-05-19 view
CXHL1500218 恩杂鲁胺胶囊 enzalutamide Capsule Chemical Drugs(3.1) New Drug Application 2015-02-26 正大天晴药业集团股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-05-19 view
CXHL1500115 恩杂鲁胺 enzalutamide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-03-06 桂林南药股份有限公司 Guilin Pharmaceutical Co Ltd Certificate Issued 2016-06-20 view
CXHL1500653 恩杂鲁胺软胶囊 enzalutamide Soft capsules Chemical Drugs(3.1) New Drug Application 2015-04-24 江苏豪森药业股份有限公司 Jiangsu Hansoh Pharmaceutical Group Co Ltd Certificate Issued 2016-08-04 view
CXHL1500651 恩杂鲁胺 enzalutamide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-04-24 连云港宏创药业有限公司 Lianyungang Hongchuang Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
CXHL1500356 恩杂鲁胺软胶囊 enzalutamide Soft capsules Chemical Drugs(3.1) New Drug Application 2015-05-28 上海星泰医药科技有限公司 Shanghai Fosun Shinotech Pharmaceutical Co Ltd Certificate Issued 2016-06-27 view
CXHL1500933 恩杂鲁胺 enzalutamide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-06-11 江西青峰药业有限公司 Jiangxi Qingfeng Pharmaceutical Industry Co Ltd Certificate Issued 2016-08-12 view
CXHL1500934 恩杂鲁胺软胶囊 enzalutamide Soft capsules Chemical Drugs(3.1) New Drug Application 2015-06-11 江西青峰药业有限公司 Jiangxi Qingfeng Pharmaceutical Industry Co Ltd Certificate Issued 2016-08-12 view
CXHL1501261 恩杂鲁胺软胶囊 enzalutamide Soft capsules Chemical Drugs(3.1) New Drug Application 2015-07-17 山西振东制药股份有限公司 Shanxi Zhendong Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
CXHL1501260 恩杂鲁胺 enzalutamide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-07-17 山西振东制药股份有限公司 Shanxi Zhendong Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
JXHL1600099 MDV3100胶囊 enzalutamide Capsule Chemical Drugs(2.4) Import Drug Application 2016-09-05 安斯泰来制药(中国)有限公司 Astellas Pharmaceutical (China) Co Ltd Certificate Issued 2017-03-27 view
JXHL1700043 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(5.1) Import Drug Application 2017-03-13 安斯泰来制药(中国)有限公司 Astellas Pharmaceutical (China) Co Ltd Certificate Issued 2017-09-28 view
JXHS1800020 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(5.1) Import Drug Application 2018-04-16 安斯泰来制药(中国)有限公司 Astellas Pharmaceutical (China) Co Ltd Certificate Issued 2019-11-25 view