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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS2000369 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(4) Generic Drug 2020-06-02 江苏豪森药业集团有限公司 Jiangsu Hansoh Pharmaceutical Group Co Ltd Certificate Issued 2021-09-02 view
JYHB2100235 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(5.1) Supplementary Application 2021-04-10 安斯泰来制药(中国)有限公司 Astellas Pharmaceutical (China) Co Ltd Certificate Completed-Pending Issued 2021-07-05 view
CYHS2100265 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(4) Generic Drug 2021-03-10 四川科伦药业股份有限公司 Sichuan Kelun Pharmaceutical Co Ltd In Review 2021-03-09 view
CYHS2100268 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(4) Generic Drug 2021-03-10 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd In Review 2021-03-09 view
CYHS2100266 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(4) Generic Drug 2021-03-10 沈阳红旗制药有限公司 Shenyang Red Flag Pharmaceutical Co Ltd In Review 2021-03-09 view
JYHL2000003 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(5.2) Import Drug Application 2020-12-18 美时化学制药股份有限公司 Lotus Pharmaceutical Co Ltd In Review 2020-12-17 view
JXHS1900163 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(5.1) Import Drug Application 2019-12-07 安斯泰来制药(中国)有限公司 Astellas Pharmaceutical (China) Co Ltd Certificate Issued 2020-11-05 view
JYHB2001671 恩扎卢胺软胶囊 enzalutamide Soft capsules Chemical Drugs(5.1) Supplementary Application 2020-09-03 安斯泰来制药(中国)有限公司 Astellas Pharmaceutical (China) Co Ltd Filed 2020-09-15 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
JTH1800397 恩杂鲁胺 enzalutamide Active ingredient Chemical Drugs Disposable Import Drug Application 2018-11-15 Laurus Labs Limited Laurus Labs Ltd Certificate Issued 2018-12-06 view
JXHL1800151 Enzalutamide软胶囊 enzalutamide Soft capsules Chemical Drugs(2.4) Import Drug Application 2018-10-31 安斯泰来制药(中国)有限公司 Astellas Pharmaceutical (China) Co Ltd In Review 2018-10-30 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
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
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
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
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